Tailored Hydration Based on Bioimpedance Analysis for Prevention of Contrast Induced Acute Kidney Injury

Not Applicable

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

• Registration Number: NCT04215042
• Lead Sponsor: Ospedale Misericordia e Dolce

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.

Study Timeline

• Study Start: 2016-05-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-29
• Study First Submitted QC: 2019-12-29
• Last Update Submitted: 2019-12-29
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard hydration	sodium chloride infusion	All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and 6 hours after procedure
Short hydration	sodium chloride infusion	All patients received shot intravenous saline hydration (3 ml/kg for 1 hour before the procedure and after 1ml/kg/h for 6 hours)

Primary Outcome Measures

Name	Time	Method
incidence of contrast induced acute kidney injury (CI-AKI)	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

Secondary Outcome Measures

Name	Time	Method
incidence of contrast induced acute kidney injury (CI-AKI)	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

Trial Locations

Locations (1)

Ospedale Santo Stefano; 🇮🇹 Prato, Italy