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

NCT04215042 | Unknown DMC

• 1 other identifier: Prato0707
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Contrast-Induced Acute Kidney Injury; Contrast-Induced Nephropathy; Contrast-Associated Acute Kidney Injury; Contrast media; Angiography; Coronary percutaneous intervention

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (1)

• incidence of contrast induced acute kidney injury (CI-AKI)

  2 days

Study Arms (2)

Standard hydration

ACTIVE COMPARATOR

All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and 6 hours after procedure

Drug: sodium chloride infusion

Short hydration

EXPERIMENTAL

All patients received shot intravenous saline hydration (3 ml/kg for 1 hour before the procedure and after 1ml/kg/h for 6 hours)

Drug: sodium chloride infusion

Interventions

sodium chloride infusion DRUG

Short hydration; Standard hydration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Misericordia e Dolce: lead

Study Sites (1)

Ospedale Santo Stefano

Prato, 59100, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 24530668 BACKGROUND

• 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.

  PMID: 29929610 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor - Cardiology

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 2, 2020
• Study Start: May 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)