Status unknownNCT04215042Hydra2Updated Jan 2, 2020

Tailored Hydration Based on Bioimpedance Analysis for Prevention of Contrast Induced Acute Kidney Injury

An interventional study of sodium chloride infusion in Acute Kidney Injury, sponsored by Ospedale Misericordia e Dolce. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-02.

Sponsored by Ospedale Misericordia e Dolce · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

Registered 3 years 7 months after the study started (first participant enrolled May 2016, registered Dec 2019).

Phase: Not applicable
Study type: Interventional
Enrollment: 1,000
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The aim of this study was to evaluate, in patients with "normal fluid status" assessed by the bio-impedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for Contrast Induced Acute Kidney Injury in patients undergoing coronary angiographic procedure.

Read the detailed description

Iodinated contrast media are a well-recognized cause of iatrogenic acute kidney injury in patients undergoing imaging diagnostic or therapeutic procedures (contrast-induced acute kidney injury, CI-AKI). Extracellular volume expansion at the time of contrast media administration may represent important protective strategies that play a major role in the prevention CI-AKI.

Bio-impedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's hydration status, and can be performed at the bedside within minutes [Maioli, Journal of American College Cardiology 1014;63:1387-94]. In this study we defined patients with "lower fluid status" with high risk of CI-AKI (Male with resistance/ height ratio > 315 Ohm/meter and Female > 380 Ohm/meter). Bio-impedance analysis IVA may represent the optimal tool to monitor the adequacy of volume expansion and protective strategy delivery.

Infusing a standardized amount of fluid before the procedure may not result in the same effects in all patients. Moreover, standardized fluid infusion for 24 hours in patients that present with "normal fluid status" assessed by the bioimpedance analysis, can represent a too expensive preventive option both in terms of care and discomfort for the patient. In this study we analyze the possibility of a non-inferiority preventive protocol that involves a lower infusion of saline solution with a shorter administration time.

Conditions studied

Acute Kidney Injury

Browse trials for

Acute Kidney Injury 1,641

Keywords

Contrast-Induced Acute Kidney Injury
Contrast-Induced Nephropathy
Contrast-Associated Acute Kidney Injury
Contrast media
Angiography
Coronary percutaneous intervention

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Ospedale Misericordia e Dolce is the lead sponsor of 11 studies on the registry; none are open to participants now.

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

Who can participate

Ages eligible: 18 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

consecutive patients admitted in Cardiology Unit for coronary or peripheral angiography with "normal fluid status" assessed on the basis bio-impedance analysis (Male with resistance/height ratio \< 315 Ohm/meter and female \< 380 Ohm/meter)

Exclusion criteria

Exclusion Criteria:

contrast medium administration within the 10 days
end stage renal failure requiring dialysis
no ability to evaluation the state of hydration with bio impedance
refused to give informed consent

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,000 participants (estimated)

Study arms

Active comparator
Standard hydration
All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and 6 hours after procedure
Drug: sodium chloride infusion
Experimental
Short hydration
All patients received shot intravenous saline hydration (3 ml/kg for 1 hour before the procedure and after 1ml/kg/h for 6 hours)
Drug: sodium chloride infusion

Interventions

Drugsodium chloride infusion

What researchers measure

Primary outcomes

incidence of contrast induced acute kidney injury (CI-AKI)
CI-AKI is defined as an increase in serum Cystatin C concentration 10%, above the baseline value, at 24 hours after administration of contrast medium
Time frame: 1 day

Secondary outcomes

incidence of contrast induced acute kidney injury (CI-AKI)
CI-AKI is defined as an increase in serum Creatinine \>= 0,3 mg/dL over baseline value within 2 days after the administration of contrast medium
Time frame: 2 days

Study locations

1 of 1 sites recruiting

Ospedale Santo Stefano
Prato, 59100, Italy
- Mauro Maioli, MD · Contact · mauro.maioli@fastwebnet.it · +39 0574803650
- Anna Toso, MD · Contact · anna.toso@libero.it · +39 0574803732
- Mauro Maioli, MD · Principal investigator
- Anna Toso, MD · Sub investigator
- Francesco Bellandi, MD · Sub investigator
- Mario Leoncini, MD · Sub investigator
Recruiting

References and documents

Publications

Maioli M, Toso A, Leoncini M, Musilli N, Bellandi F, Rosner MH, McCullough PA, Ronco C. Pre-procedural bioimpedance vectorial analysis of fluid status and prediction of contrast-induced acute kidney injury. J Am Coll Cardiol. 2014 Apr 15;63(14):1387-94. doi: 10.1016/j.jacc.2014.01.025. Epub 2014 Feb 12. PubMed 24530668 ↗
Maioli M, Toso A, Leoncini M, Musilli N, Grippo G, Ronco C, McCullough PA, Bellandi F. Bioimpedance-Guided Hydration for the Prevention of Contrast-Induced Kidney Injury: The HYDRA Study. J Am Coll Cardiol. 2018 Jun 26;71(25):2880-2889. doi: 10.1016/j.jacc.2018.04.022. PubMed 29929610 ↗

Individual participant data

Plan to share: No

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

Started May 2016 (actual). Primary completion is estimated for Dec 2019, 43 months after the start.

Of 239 non-industry interventional studies with no phase under Acute Kidney Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 44. This study's planned 43 months is above that.

Counting every sponsor, half of 255 studies reached it within 26 months; a quarter within 12 and three quarters within 44.

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

Registered: Dec 29, 2019
First posted: Jan 2, 2020
StartActual: May 1, 2016
Primary completionEst.: Dec 31, 2019
CompletionEst.: Dec 31, 2019
Last update: Jan 2, 2020

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 Jan 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04215042
Lead sponsor: Ospedale Misericordia e Dolce
Responsible party: Mauro Maioli (Medical Doctor - Cardiology, Ospedale Misericordia e Dolce) — Principal investigator
First posted: Jan 2, 2020
Start date: May 1, 2016
Primary completion: Dec 31, 2019 (estimated)
Completion: Dec 31, 2019 (estimated)
Last update: Jan 2, 2020

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Sodium Chloride

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