Tailored Hydration Based on Bioimpedance Analysis for Prevention of Contrast Induced Acute Kidney Injury (Hydra2)
Primary Purpose
Acute Kidney Injury
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
sodium chloride infusion
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury focused on measuring Contrast-Induced Acute Kidney Injury, Contrast-Induced Nephropathy, Contrast-Associated Acute Kidney Injury, Contrast media, Angiography, Coronary percutaneous intervention
Eligibility Criteria
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
Sites / Locations
- Ospedale Santo StefanoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard hydration
Short hydration
Arm Description
All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and 6 hours after procedure
All patients received shot intravenous saline hydration (3 ml/kg for 1 hour before the procedure and after 1ml/kg/h for 6 hours)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04215042
First Posted
December 29, 2019
Last Updated
December 29, 2019
Sponsor
Ospedale Misericordia e Dolce
1. Study Identification
Unique Protocol Identification Number
NCT04215042
Brief Title
Tailored Hydration Based on Bioimpedance Analysis for Prevention of Contrast Induced Acute Kidney Injury
Acronym
Hydra2
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Misericordia e Dolce
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Contrast-Induced Acute Kidney Injury, Contrast-Induced Nephropathy, Contrast-Associated Acute Kidney Injury, Contrast media, Angiography, Coronary percutaneous intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard hydration
Arm Type
Active Comparator
Arm Description
All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and 6 hours after procedure
Arm Title
Short hydration
Arm Type
Experimental
Arm Description
All patients received shot intravenous saline hydration (3 ml/kg for 1 hour before the procedure and after 1ml/kg/h for 6 hours)
Intervention Type
Drug
Intervention Name(s)
sodium chloride infusion
Primary Outcome Measure Information:
Title
incidence of contrast induced acute kidney injury (CI-AKI)
Description
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 Outcome Measure Information:
Title
incidence of contrast induced acute kidney injury (CI-AKI)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ospedale Santo Stefano
City
Prato
ZIP/Postal Code
59100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro Maioli, MD
Phone
+39 0574803650
Email
mauro.maioli@fastwebnet.it
First Name & Middle Initial & Last Name & Degree
Anna Toso, MD
Phone
+39 0574803732
Email
anna.toso@libero.it
First Name & Middle Initial & Last Name & Degree
Mauro Maioli, MD
First Name & Middle Initial & Last Name & Degree
Anna Toso, MD
First Name & Middle Initial & Last Name & Degree
Francesco Bellandi, MD
First Name & Middle Initial & Last Name & Degree
Mario Leoncini, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24530668
Citation
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.
Results Reference
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PubMed Identifier
29929610
Citation
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.
Results Reference
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Tailored Hydration Based on Bioimpedance Analysis for Prevention of Contrast Induced Acute Kidney Injury
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