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

Phase 4

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: sodium chloride infusion

• Registration Number: NCT02225431
• Lead Sponsor: Ospedale Misericordia e Dolce

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2014-08-24
• Study First Submitted QC: 2014-08-24
• Study First Posted: 2014-08-26
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard saline infusion	sodium chloride infusion	All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and after procedure)
Double saline infusion	sodium chloride infusion	All patients received double dose of intravenous saline hydration (0.9% sodium chloride, 2 ml/kg/h for 12 hours before and after procedure)

Primary Outcome Measures

Name	Time	Method
Incidence of contrast-induced acute kidney injury	1 day	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

Name	Time	Method
Adverse clinical events	1 month	adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration

Trial Locations

Locations (1)

Ospedale Santo Stefano; 🇮🇹 Prato, Italy