Personalized Versus Standard Hydration for Prevention of CI-AKI: a Randomized Trial With Bioimpedance Analysis

Acute Kidney Injury Clinical Trial

Official title:

Personalized Versus Standard Hydration for Prevention of Contrast Induced Acute Kidney Injury. A Randomized Trial With Bioimpedance Analysis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225431
• Other study ID #: Prato0706
• Secondary ID: 2013/1
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2014
• Last updated: October 15, 2015
• Start date: September 2012
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Ospedale Misericordia e Dolce
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• sodium chloride infusion

Locations

Country	Name	City	State
Italy	Ospedale Santo Stefano	Prato

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Misericordia e Dolce

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of contrast-induced acute kidney injury	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	2 days	Yes
Primary	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	1 day	Yes
Secondary	Adverse clinical events	adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration	1 month	Yes