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CompletedNCT03476460PNIC-NaUpdated Mar 20, 2025Results posted

Sodium Chloride and Contrast Nephropathy

A Phase 2 interventional study of Oral sodium chloride and Intravenous sodium chloride in Kidney Failure, Chronic, Kidney Failure, Acute and Heart Failure, sponsored by Hospital Universitario Ramon y Cajal. Completed at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.

Sponsored by Hospital Universitario Ramon y Cajal · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Apr 2014, registered Mar 2018).
Phase
Phase 2
Study type
Interventional
Enrollment
271
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast.

Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.

The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol.

Patients >65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate \<30 ml/min, serum potassium \<3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.

Contrast nephropathy will be defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline, in the first 48 hours after contrast administration.

Read the detailed description

This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast.

Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.

In those patients randomly allocated to oral prophylaxis (n=133), patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast. In those patients randomly allocated to receive sodium chloride 0.9% intravenous solution (n=133), patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection. The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol (320 mg of iodine/ml, in 100 ml, at an infusion rate of 2-5 ml/sec).

Patients >65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate \<30 ml/min, serum potassium \<3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.

Contrast nephropathy will be defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline, in the first 48 hours after contrast administration.

02

Conditions studied

  • Kidney Failure, Chronic
  • Kidney Failure, Acute
  • Heart Failure
  • Diabetes

Keywords

  • Acute kidney failure
  • CT scan
  • Iodine contrast
  • Sodium chloride
03

In context

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's enrollment of 271 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Hospital Universitario Ramon y Cajal is the lead sponsor of 30 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients >65 years,
  • Both sexes,
  • With at least one of the following criteria: diabetes or stable heart failure or chronic kidney disease (estimated between 30 and 60 ml/min),
  • Undergoing CT scan with contrast
  • Written .

Exclusion criteria

Exclusion Criteria:

  • Estimated \<30 ml/min,
  • Serum potassium \<3.5 mEq/L,
  • Infusion of iodine contrast in the previous 15 days,
  • Administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion,
  • Decompensated chronic conditions (heart failure, , hypertension),
  • Allergy to iodine contrast,
  • Presence of hyperchloremia or hypernatremia.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
271 participants (actual)

Study arms

  • Experimental
    Oral sodium chloride

    Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.

    Drug: Oral sodium chloride

  • Active comparator
    Intravenous sodium chloride

    Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.

    Drug: Intravenous sodium chloride

Interventions

  • DrugOral sodium chloride

    Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.

  • DrugIntravenous sodium chloride

    Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration

    Contrast-Associated Acute Kidney Injury, defined as the increase of serum creatinine \>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \>25%, within 48h after contrast administration

    Time frame: Within 48h after contrast administration

Secondary outcomes

  1. Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline

    Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 24 hours from contrast administration (baseline)

  2. Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline

    Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 48 hours from contrast administration (baseline)

  3. Serum Creatinine at 24h From Baseline

    Serum creatinine at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 24 hours from contrast administration (baseline)

  4. Serum Creatinine at 48h From Baseline

    Serum creatinine at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 48 hours from contrast administration (baseline)

  5. Cystatin C at 24h From Baseline

    Cystatin C at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 24 hours from contrast administration (baseline)

  6. Cystatin C at 48h From Baseline

    Cystatin C at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 48 hours from contrast administration (baseline)

  7. Albumin-to-creatinine Ratio at 24h From Baseline

    Albumin-to-creatinine ratio at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 24 hours from contrast administration (baseline)

  8. Albumin-to-creatinine Ratio at 48h From Baseline

    Albumin-to-creatinine ratio at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 48 hours from contrast administration (baseline)

  9. Urea at 24h From Baseline

    Urea at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 24 hours from contrast administration (baseline)

  10. Urea at 48h From Baseline

    Urea at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 48 hours from contrast administration (baseline)

  11. Serum Sodium at 24h From Baseline

    Serum sodium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 24 hours from contrast administration (baseline)

  12. Serum Sodium at 48h From Baseline

    Serum sodium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 48 hours from contrast administration (baseline)

  13. Serum Potassium at 24h From Baseline

    Serum potassium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 24 hours from contrast administration (baseline)

  14. Serum Potassium at 48h From Baseline

    Serum potassium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

    Time frame: 48 hours from contrast administration (baseline)

07

Results

Posted Mar 20, 2025
Limitations and caveats
The incidence of CA-AKI was much lower than expected at the time of study design. The definition of CA-AKI considered in our study is slightly different from that proposed in the clinical guidelines for AKI. Serial measurements of serum and urinary osmolality were not available in our trial. The trial was a single-center study, which might limit its external validity.

Participant flow

Participants were recruited at Hospital Universitario Ramón y Cajal, Madrid, Spain, between April 2014 and November 2019.

Participant flow — Overall Study
MilestoneOral Sodium ChlorideIntravenous Sodium Chloride
Started134137
Completed123129
Not completed118
Withdrew: Withdrawal by subject32
Withdrew: Non-compliance with treatment30
Withdrew: Missing laboratory tests55
Withdrew: Adverse event01

Outcome measures

PrimaryNumber of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration

Contrast-Associated Acute Kidney Injury, defined as the increase of serum creatinine \>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \>25%, within 48h after contrast administration

Time frame:
Within 48h after contrast administration
Reported as:
Count of participants · Participants
Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration
ParticipantsOral Sodium ChlorideIntravenous Sodium Chloride
Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration54
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · Risk difference (rd): 1.0 · 95% CI -4.8 to 7.0The 95% confidence interval for the difference between the two independent proportions was calculated according to Wilson's method.
SecondaryEstimated Glomerular Filtration Rate (eGFR) at 24h From Baseline

Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
24 hours from contrast administration (baseline)
Reported as:
Mean · mL/min/1.73 m^2
Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline
mL/min/1.73 m^2Oral Sodium ChlorideIntravenous Sodium Chloride
Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline66.4 ± 18.968.8 ± 18.9
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.299 (A p-value \<0.05 (two-sided) was considered for statistical significance.)
SecondaryEstimated Glomerular Filtration Rate (eGFR) at 48h From Baseline

Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
48 hours from contrast administration (baseline)
Reported as:
Mean · mL/min/1.73 m^2
Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline
mL/min/1.73 m^2Oral Sodium ChlorideIntravenous Sodium Chloride
Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline66.1 ± 19.767.9 ± 19.6
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.477 (A p-value \<0.05 (two-sided) was considered for statistical significance.)
SecondarySerum Creatinine at 24h From Baseline

Serum creatinine at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
24 hours from contrast administration (baseline)
Reported as:
Mean · mg/dL
Serum Creatinine at 24h From Baseline
mg/dLOral Sodium ChlorideIntravenous Sodium Chloride
Serum Creatinine at 24h From Baseline1.10 ± 0.331.02 ± 0.29
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.042 (A p-value \<0.05 (two-sided) was considered for statistical significance.)
SecondarySerum Creatinine at 48h From Baseline

Serum creatinine at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
48 hours from contrast administration (baseline)
Reported as:
Mean · mg/dL
Serum Creatinine at 48h From Baseline
mg/dLOral Sodium ChlorideIntravenous Sodium Chloride
Serum Creatinine at 48h From Baseline1.10 ± 0.361.04 ± 0.31
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.121 (A p-value \<0.05 (two-sided) was considered for statistical significance)
SecondaryCystatin C at 24h From Baseline

Cystatin C at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
24 hours from contrast administration (baseline)
Reported as:
Mean · mg/dL
Cystatin C at 24h From Baseline
mg/dLOral Sodium ChlorideIntravenous Sodium Chloride
Cystatin C at 24h From Baseline1.38 ± 0.441.33 ± 0.46
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.418 (A p-value \<0.05 (two-sided) was considered for statistical significance.)
SecondaryCystatin C at 48h From Baseline

Cystatin C at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
48 hours from contrast administration (baseline)
Reported as:
Mean · mg/dL
Cystatin C at 48h From Baseline
mg/dLOral Sodium ChlorideIntravenous Sodium Chloride
Cystatin C at 48h From Baseline1.36 ± 0.431.36 ± 0.46
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.901 (A p-value \<0.05 (two-sided) was considered for statistical significance)
SecondaryAlbumin-to-creatinine Ratio at 24h From Baseline

Albumin-to-creatinine ratio at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
24 hours from contrast administration (baseline)
Reported as:
Median · mg/g
Albumin-to-creatinine Ratio at 24h From Baseline
mg/gOral Sodium ChlorideIntravenous Sodium Chloride
Albumin-to-creatinine Ratio at 24h From Baseline17.2 (8.3 to 72.0)17.0 (9.3 to 65.5)
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · Wilcoxon (Mann-Whitney) · p = 0.720 (A p-value \<0.05 (two-sided) was considered for statistical significance)
SecondaryAlbumin-to-creatinine Ratio at 48h From Baseline

Albumin-to-creatinine ratio at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
48 hours from contrast administration (baseline)
Reported as:
Median · mg/g
Albumin-to-creatinine Ratio at 48h From Baseline
mg/gOral Sodium ChlorideIntravenous Sodium Chloride
Albumin-to-creatinine Ratio at 48h From Baseline17.6 (9.0 to 69.2)18.2 (9.0 to 50.1)
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · Wilcoxon (Mann-Whitney) · p = 0.688 (A p-value \<0.05 (two-sided) was considered for statistical significance)
SecondaryUrea at 24h From Baseline

Urea at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
24 hours from contrast administration (baseline)
Reported as:
Mean · mg/dL
Urea at 24h From Baseline
mg/dLOral Sodium ChlorideIntravenous Sodium Chloride
Urea at 24h From Baseline43.7 ± 18.742.2 ± 18.2
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.535 (A p-value \<0.05 (two-sided) was considered for statistical significance)
SecondaryUrea at 48h From Baseline

Urea at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
48 hours from contrast administration (baseline)
Reported as:
Mean · mg/dL
Urea at 48h From Baseline
mg/dLOral Sodium ChlorideIntravenous Sodium Chloride
Urea at 48h From Baseline46.0 ± 19.543.5 ± 20.1
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.338 (A p-value \<0.05 (two-sided) was considered for statistical significance)
SecondarySerum Sodium at 24h From Baseline

Serum sodium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
24 hours from contrast administration (baseline)
Reported as:
Mean · mg/dL
Serum Sodium at 24h From Baseline
mg/dLOral Sodium ChlorideIntravenous Sodium Chloride
Serum Sodium at 24h From Baseline139.4 ± 2.6139.3 ± 2.6
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.764 (A p-value \<0.05 (two-sided) was considered for statistical significance)
SecondarySerum Sodium at 48h From Baseline

Serum sodium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
48 hours from contrast administration (baseline)
Reported as:
Mean · mg/dL
Serum Sodium at 48h From Baseline
mg/dLOral Sodium ChlorideIntravenous Sodium Chloride
Serum Sodium at 48h From Baseline139.2 ± 2.7139.4 ± 2.6
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.458 (A p-value \<0.05 (two-sided) was considered for statistical significance.)
SecondarySerum Potassium at 24h From Baseline

Serum potassium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
24 hours from contrast administration (baseline)
Reported as:
Mean · mg/dL
Serum Potassium at 24h From Baseline
mg/dLOral Sodium ChlorideIntravenous Sodium Chloride
Serum Potassium at 24h From Baseline4.4 ± 0.44.4 ± 0.5
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.893 (A p-value \<0.05 (two-sided) was considered for statistical significance.)
SecondarySerum Potassium at 48h From Baseline

Serum potassium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.

Time frame:
48 hours from contrast administration (baseline)
Reported as:
Mean · mg/dL
Serum Potassium at 48h From Baseline
mg/dLOral Sodium ChlorideIntravenous Sodium Chloride
Serum Potassium at 48h From Baseline4.4 ± 0.44.5 ± 0.5
Statistical analysis
  • Oral Sodium Chloride vs Intravenous Sodium Chloride · t-test, 2 sided · p = 0.645 (A p-value \<0.05 (two-sided) was considered for statistical significance.)

Adverse events

Collected over Within 48 hours from contrast administration (baseline).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oral Sodium Chloride0/134 (0%)0/134 (0%)31/134 (23.1%)
Intravenous Sodium Chloride0/137 (0%)0/137 (0%)6/137 (4.4%)
Most frequent other events
Showing 10 of 12
Most frequent other events
EventOral Sodium ChlorideIntravenous Sodium Chloride
NauseaGastrointestinal disorders13/1340/137
VomitingGastrointestinal disorders10/1340/137
Abdominal discomfortGastrointestinal disorders3/1340/137
DyspneaRespiratory, thoracic and mediastinal disorders0/1342/137
Malaise/astheniaGeneral disorders1/1341/137
HeadacheNervous system disorders1/1340/137
Leg crampsMusculoskeletal and connective tissue disorders1/1340/137
PruritusSkin and subcutaneous tissue disorders1/1340/137
Allergic reaction to contrastImmune system disorders1/1340/137
BronchospasmRespiratory, thoracic and mediastinal disorders0/1341/137

Baseline characteristics

Age, Continuous
Age, Continuous(years)Oral Sodium ChlorideIntravenous Sodium ChlorideTotal
Mean74.1 ± 6.174.6 ± 6.874.4 ± 6.4
Sex: Female, Male
Sex: Female, Male(Participants)Oral Sodium ChlorideIntravenous Sodium ChlorideTotal
Female345084
Male8979168
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Oral Sodium ChlorideIntravenous Sodium ChlorideTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Oral Sodium ChlorideIntravenous Sodium ChlorideTotal
Spain123129252
Hypertension
Hypertension(Participants)Oral Sodium ChlorideIntravenous Sodium ChlorideTotal
Count of participants9498192
Diabetes
Diabetes(Participants)Oral Sodium ChlorideIntravenous Sodium ChlorideTotal
Count of participants8797184
Current smoker
Current smoker(Participants)Oral Sodium ChlorideIntravenous Sodium ChlorideTotal
Count of participants5914
Cancer
Cancer(Participants)Oral Sodium ChlorideIntravenous Sodium ChlorideTotal
Count of participants6859127

20 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Hospital Universitario Ramon y Cajal
    Madrid, 28034, Spain
09

References and documents

Publications

  • Suarez Carantona C, Escobar Cervantes C, Fabregate M, Lopez Rodriguez M, Bara Ledesma N, Soto Perez-Olivares J, Ruiz Ortega RA, Lopez Castellanos G, Olavarria Delgado A, Blazquez Sanchez J, Gomez Del Olmo V, Moralejo Martin M, Pumares Alvarez MB, Sanchez Gallego MC, Llacer P, Liano F, Manzano L. Oral Sodium Chloride in the Prevention of Contrast-Associated Acute Kidney Injury in Elderly Outpatients: The PNIC-Na Randomized Non-Inferiority Trial. J Clin Med. 2023 Apr 19;12(8):2965. doi: 10.3390/jcm12082965. PubMed 37109303 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Data Availability Statement The data presented in this study are available on request from the corresponding author. The data are not publicly available due to participant confidentiality.

Supporting information: Study protocol, Informed consent form

Time frame: After revision and approval of the principal investigator.

Access criteria: Approval of the principal investigator.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2014 to primary completion in Nov 2019, 67 months.

Results were first posted in Mar 2025, 5 years 3 months after primary completion.

Of 41 non-industry phase 2 interventional studies under Kidney Failure, Chronic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 52. This study's 67 months is above that.

Counting every sponsor, half of 67 studies reached it within 32 months; a quarter within 17 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2018
First posted
Mar 26, 2018
StartActual
Apr 1, 2014
Primary completionActual
Nov 29, 2019
CompletionActual
Nov 29, 2019
Results first posted
Mar 20, 2025
Last update
Mar 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03476460
Lead sponsor
Hospital Universitario Ramon y Cajal
Collaborators
Instituto de Salud Carlos III, Ministerio de Sanidad, Servicios Sociales e Igualdad
Responsible party
Luis Manzano Espinosa (MD, PhD, Chief of Internal Medicine department, Hospital Universitario Ramon y Cajal) — Principal investigator
First posted
Mar 26, 2018
Start date
Apr 1, 2014
Primary completion
Nov 29, 2019
Completion
Nov 29, 2019
Results posted
Mar 20, 2025
Last update
Mar 20, 2025

Study contacts

Luis Manzano, MD, PhD
principal investigator · Hospital Universitario Ramon y Cajal

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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