Personalized Versus Standard Hydration for Prevention of CI-AKI: a Randomized Trial With Bioimpedance Analysis
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Phase 4
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 nephropathy, Contrast-Induced 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 "lower fluid status" defined 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
- refused to give informed consent
Sites / Locations
- Ospedale Santo Stefano
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard saline infusion
Double saline infusion
Arm Description
All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and after procedure)
All patients received double dose of intravenous saline hydration (0.9% sodium chloride, 2 ml/kg/h for 12 hours before and after procedure)
Outcomes
Primary Outcome Measures
Incidence of contrast-induced acute kidney injury
contrast acute kidney injury 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
Adverse clinical events
adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration
Full Information
NCT ID
NCT02225431
First Posted
August 24, 2014
Last Updated
October 15, 2015
Sponsor
Ospedale Misericordia e Dolce
1. Study Identification
Unique Protocol Identification Number
NCT02225431
Brief Title
Personalized Versus Standard Hydration for Prevention of CI-AKI: a Randomized Trial With Bioimpedance Analysis
Official Title
Personalized Versus Standard Hydration for Prevention of Contrast Induced Acute Kidney Injury. A Randomized Trial With Bioimpedance Analysis.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Misericordia e Dolce
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to evaluate, in patients with "lower fluid status" defined by bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for CI-AKI in patients undergoing coronary angiographic procedures.
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).
Several protocols have been tested for the prevention of CI-AKI, including periprocedural hydration with isotonic saline or sodium bicarbonate, antioxidant compounds, use of low- or iso-osmolar contrast agents, and hemofiltration or dialysis. The results of these interventions and strategies have been often disappointing or inconclusive and intravenous volume expansion remains the only therapy of undisputed efficacy.
Bioimpedance 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, JACC 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). BIVA may represent the optimal tool to monitor the adequacy of volume expansion and protective strategy delivery.
However, most hydration protocols rely on a "one size fits all" approach with a fixed volume and time of infusion without an assessment of whether adequate hydration was achieved. This practice risks either under-hydration without true amelioration of CI-AKI risk or over-hydration with risk of adverse outcomes.
Thus, on the basis of results of BIVA testing a randomized fluid infusion plan is prescribed.
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 nephropathy, Contrast-Induced acute kidney injury, Contrast media, Angiography, Coronary percutaneous intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
296 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard saline infusion
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 after procedure)
Arm Title
Double saline infusion
Arm Type
Experimental
Arm Description
All patients received double dose of intravenous saline hydration (0.9% sodium chloride, 2 ml/kg/h for 12 hours before and after procedure)
Intervention Type
Drug
Intervention Name(s)
sodium chloride infusion
Primary Outcome Measure Information:
Title
Incidence of contrast-induced acute kidney injury
Description
contrast acute kidney injury 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
Adverse clinical events
Description
adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Incidence of contrast-induced acute kidney injury
Description
Contrast-induced acute kidney injury 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
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
consecutive patients admitted in Cardiology Unit for coronary or peripheral angiography with "lower fluid status" defined 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
refused to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Maioli, MD
Organizational Affiliation
Ospedale S. Stefano - Prato - Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Santo Stefano
City
Prato
ZIP/Postal Code
59100
Country
Italy
12. IPD Sharing Statement
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
background
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
derived
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Personalized Versus Standard Hydration for Prevention of CI-AKI: a Randomized Trial With Bioimpedance Analysis
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