Tailored Hydration Based on Bioimpedance Analysis for Prevention of Contrast Induced Acute Kidney Injury (Hydra2)
Prevention of Contrast-Induced Acute Kidney Injury: Standard Versus Short Hydration Protocol in Patients With Normal Fluid Status Assessed by the Bioimpedance Analysis (The HYDRA II Study)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Prato, Italy, 59100
- Recruiting
- Ospedale Santo Stefano
-
Sub-Investigator:
- Francesco Bellandi, MD
-
Sub-Investigator:
- Mario Leoncini, MD
-
Contact:
- Mauro Maioli, MD
- Phone Number: +39 0574803650
- Email: mauro.maioli@fastwebnet.it
-
Contact:
- Anna Toso, MD
- Phone Number: +39 0574803732
- Email: anna.toso@libero.it
-
Principal Investigator:
- Mauro Maioli, MD
-
Sub-Investigator:
- Anna Toso, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
|
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of contrast induced acute kidney injury (CI-AKI)
Time Frame: 1 day
|
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
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of contrast induced acute kidney injury (CI-AKI)
Time Frame: 2 days
|
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
|
2 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prato0707
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.