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Status unknownNCT02449382Updated Jul 13, 2015

Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia

An interventional study of continuous venovenous hemofiltration and Control group in Hypernatremia and Critically Ill, sponsored by Air Force Military Medical University, China. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-13.

Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The patients with severe hypernatremia who received conventional treatment are often undertreated. Continuous venovenous hemofiltration (CVVH) can effectively remove solute or water from circulation system. Several case reports demonstrated that CVVH could effectively decrease serum sodium concentration of the patients with severe hypernatremia. The use of CVVH for acute severe hypernatremia in critically ill patients could improve patient survival by effectively decreasing the serum sodium concentration to a normal level.

Read the detailed description

Date collection:

  1. Demographic (gender, age, race, weight, history of drug allergy, complicating diseases, drug combination and combination therapy)
  2. CVVH treatment (time, blood vessel, blood flow, replacement fluid flow, the type and dose of anticoagulant, limited to the test group)
  3. Vital signs (blood pressure, heart rate, respiratory frequency, body temperature)
  4. Severity of disease
  5. General treatment (Vasoactive drugs, mechanical ventilation, diuretic, steroid hormones) 6.24 hours input 7.24 hour output

8.Daily sodium intake 9.Adverse events were confirmed 10.Laboratory date: Routine blood test Blood biochemical Blood gas analysis Blood electrolyte Plasma osmotic pressure Urine osmotic pressure Plasma osmotic pressure Urinary electrolyte excretion fraction

02

Conditions studied

  • Hypernatremia
  • Critically Ill

Keywords

  • continuous venovenous hemofiltration
  • conventional treatment
  • mortality
  • acute severe hypernatremia
03

Who can participate

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

Inclusion criteria

  1. Age≥18 years
  2. Acute severe hypernatremia(increasing of serum sodium levels from normal levels to ≥160 mmol/L within 48 hours)
  3. ICU patients

Exclusion criteria

Exclusion Criteria:

  1. Hypovolemic hypernatremia fractional excretion of sodium \<0.5% and Urea/Creatinine >40 receiving diuretics: Urea/Creatinine >40, No edema.
  2. Acute kidney injure network III
  3. End-stage renal disease Hemodialysis or peritoneal dialysis
  4. K+>6.5mmol/L The drug is difficult to treat hyperkalemia
  5. Hydrogen ion concentration\<7.2 The drug is difficult to treat metabolic acidosis
  6. Acute pulmonary edema
  7. Systolic blood pressure \<90 mmHg vasoactive drugs in the treatment of systolic blood pressure less than 90 mmHg
  8. The heparin or low molecular allergic patients
  9. HIV positive patients
  10. Pregnant women or lactational pregnancy women
  11. Suspected tuberculosis patients
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    continuous venovenous hemofiltration

    CVVH was mainly determined by the differences of sodium concentration between serum and replacement fluid. The rate of decline serum sodium could be real-time adjusted using different-sodium-concentration replacement fluid according to the updated serum sodium concentration.

    Procedure: continuous venovenous hemofiltration

  • Active comparator
    Control group

    Treatment of hypernatremia is correction of water deficit.

    Drug: Control group

Interventions

  • Procedurecontinuous venovenous hemofiltration

    If the serum sodium concentration \>150mmol/L, When filter occurred clotting, replace the filter to CVVH treatment

    Also known as: continuous renal replacement therapy

  • DrugControl group

    If the serum sodium concentration ≤150mmol/L, When filter occurred clotting, as the end of treatment.

    Also known as: standard treatments

05

What researchers measure

Primary outcomes

  1. 7-day all cause mortality

    Time frame: 7days

Secondary outcomes

  1. Glasgow Coma score changes

    On the third day of the Glasgow Coma score minus baseline of the Glasgow Coma score

    Time frame: 3 days

  2. Sequential Organ Failure Assessment score changes

    On the third day of the Sequential Organ Failure Assessment score minus baseline of the Sequential Organ Failure Assessment score

    Time frame: 3 days

  3. Acute Physiology and Chronic Health Evaluation II score changes

    On the third day of the Acute Physiology and Chronic Health Evaluation II score minus baseline of the Acute Physiology and Chronic Health Evaluation II score

    Time frame: 3 days

  4. The average reduce rate of serum sodium

    The average reduce rate of serum sodium was calculated as following: (serum sodium concentration before treatment (mmol/L) - serum sodium concentration after treatment (mmol/L)) / time after treatment (hours)

    Time frame: 3 days

  5. 24-hour correction of hypernatremia

    Twenty-four-hour correction of hypernatremia was defined as the reduction of serum sodium concentration to ≤145 mmol/L within 24 hours after the start of treatment.

    Time frame: 24-hour

06

Study locations

1 of 1 sites recruiting
  • Xijing Hospital of Nephrology
    Xi'an, Shaanxi 710032, China
    Recruiting
07

References and documents

Publications

  • Huang C, Zhang P, Du R, Li Y, Yu Y, Zhou M, Jing R, Li L, Zheng Y, Wang H, Liu H, He L, Sun S. Treatment of acute hypernatremia in severely burned patients using continuous veno-venous hemofiltration with gradient sodium replacement fluid: a report of nine cases. Intensive Care Med. 2013 Aug;39(8):1495-6. doi: 10.1007/s00134-013-2933-9. Epub 2013 May 8. No abstract available. PubMed 23653182 ↗
08

Registry details

Key details

Study ID
NCT02449382
Lead sponsor
Air Force Military Medical University, China
Responsible party
Shiren sun (M.D., Air Force Military Medical University, China) — Principal investigator
First posted
May 20, 2015
Start date
Jun 2015
Primary completion
Jun 2017 (estimated)
Completion
Jun 2017 (estimated)
Last update
Jul 13, 2015

Study contacts

Shiren Sun, M.D.
Contact
sunshiren@medmail.com.cn
+8602984775193
Feng Ma, M.D.
Contact
28186432@qq.com
+8602984775193
Shiren Sun, M.D.
principal investigator · the First Affiliated Hospital of Fourth Military Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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