Preventing Contrast-induced Nephropathy: Evaluating Hydration Strategies and L-carnitine Administration

NCT01786824 | Terminated Phase 3 DMC

• 2 other identifiers: LOCAL/2012/PR-032012-004134-42
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 5

Brief Summary

The general objective of this open, pilot study is to characterize biological parameters related to acute kidney injury among patients undergoing a programmed coronarography with injection of contrast material. The study focuses on two main factors that may influence acute kidney injury: (1) sodium chloride hydration strategy versus sodium bicarbonate hydration strategy and (2) presence of oral L-carnitine treatment versus absence of oral L-carnitine treatment. We will also test for a potential interaction between these two factors.

Conditions

Acute Kidney Injury; Renal Insufficiency

Keywords

contrast induced nephropathy; hydration strategy; L-carnitine

Outcome Measures

Primary Outcomes (1)

• Change in glomerular filtration rate

  The change in MDRD glomerular filtration rate before coronarography, and 48 hours after the injection of contrast material.

  baseline versus 48 hours after contrast injection

Secondary Outcomes (17)

• Contrast induced nephropathy?

  Day 2

• Contrast induced nephropathy?

  Day 3

• Contrast induced nephropathy?

  Day 7

• Change in creatinemia

  baseline versus Day 2

• Change in creatinemia

  baseline versus Day 3

Study Arms (4)

Bicarbonate

EXPERIMENTAL

The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy containing sodium bicarbonate. Intervention: Hydration strategy using sodium bicarbonate Intervention: Coronarography

Drug: Hydration strategy using sodium bicarbonate; Procedure: Coronarography

Saline

ACTIVE COMPARATOR

The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy using sodium chloride solution. Intervention: Hydration strategy using saline Intervention: Coronarography

Drug: Hydration strategy using saline; Procedure: Coronarography

Bicar + L-Carnitine

EXPERIMENTAL

The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy containing sodium bicarbonate. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7. Intervention: Hydration strategy using sodium bicarbonate Intervention: L-carnitine Intervention: Coronarography

Drug: Hydration strategy using sodium bicarbonate; Drug: L-carnitine; Procedure: Coronarography

Saline + L-carnitine

EXPERIMENTAL

The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy using sodium chloride solution. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7. Intervention: Hydration strategy using saline Intervention: L-carnitine Intervention: Coronarography

Drug: Hydration strategy using saline; Drug: L-carnitine; Procedure: Coronarography

Interventions

Hydration strategy using saline DRUG

For 12 hours preceding the coronarography, and for 12 following the coronarography, 0.9% sodium chloride at 1 ml/kg/h is administered via a slow intravenous perfusion.

Also known as: Sodium chloride hydration

Saline; Saline + L-carnitine

Hydration strategy using sodium bicarbonate DRUG

For 4-6 hours before the coronarography and for 4-6 hours after the coronarography, 500 ml of isotonic sodium bicarbonate solution (1.4%) will be administered via a slow intravenous solution.

Bicar + L-Carnitine; Bicarbonate

L-carnitine DRUG

Before the coronarography (D-1), 1 gram of L-carnitine is administered via an oral solution that can be diluted in a small amount of sugar water if necessary. This administration corresponds to the beginning of a hydration protocol. For days 0 to 7 after the coronarography, patients are administered an oral L-carnitine solution (3 grams of L-carnitine per day). The latter may be diluted in a small amount of sugar water if needed.

Bicar + L-Carnitine; Saline + L-carnitine

Coronarography PROCEDURE

All patients included in this study are programmed for a coronarography with injection of contrast material (either iodixanol or ioxaglate). The day of coronarography = Day 0.

Bicar + L-Carnitine; Bicarbonate; Saline; Saline + L-carnitine

Eligibility Criteria

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

You may qualify if:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is scheduled for a coronarography
• The patient can come back to the hospital on days 2 and 7 after the coronarography for follow up
• The patient has moderate to severe renal insufficiency (glomerular filtration rate \< 60 ml / min / 1.73 m\^2)
• The patient has not had any oral antidiabetic treatments, or diuretic treatments, within 48 hours preceding the coronarography
• Lack of treatment with ACE inhibitors or ARA2 24 hours prior to coronary

You may not qualify if:

• The patient is participating in another study
• The patient is under judicial protection
• The patient is under any kind of guardianship
• The patient refuses to sign the consent form
• It is impossible to correctly inform the patient
• The patient is unable to participate in follow-up visits at days 2 and 7 after the coronarography
• The patient is pregnant or breastfeeding
• The patient is taking L-carnitine
• The patient has a contra indication for a treatment used in this study
• Acute heart failure
• Infarction, acute phase
• Hemodialysis patient
• Myeloma
• Epileptic patient treated with Depakine (valproic acid) (carnitine can lower epilepsy-related thresholds by speeding up the metabolism of Depakine)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (5)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

CHU d'Angers - Hôtel-Dieu

Angers, 49933, France

Location

CH d'Avignon - Centre Hospitalier Henri Duffaut

Avignon, 84902, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CH de Perpignan - Hôpital Saint Jean

Perpignan, 66046, France

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency

Interventions

Carnitine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Pascal Reboul, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

FR (5)