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

Phase 3TerminatedNCT01786824

Centre Hospitalier Universitaire de Nīmes9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Acute Kidney Injury Renal Insufficiency

Interventions

Hydration strategy using sodium bicarbonateDRUG

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.

L-carnitineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * The patient is participating in another study * The patient is in an exclusion period determined by 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)

Locations (5)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

CHU d'Angers - Hôtel-Dieu

Angers, France

CH d'Avignon - Centre Hospitalier Henri Duffaut

Avignon, France

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, France

CH de Perpignan - Hôpital Saint Jean

Perpignan, France

Outcomes

Primary Outcomes

Change in glomerular filtration rate

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

Time frame: baseline versus 48 hours after contrast injection

Secondary Outcomes

Contrast induced nephropathy?

The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following: 1. a \>= 25% increase in creatinemia as compared to baseline 2. an absolute increase \>= 44 µmol/L in creatinemia as compared to baseline 3. a decrease \>= 25% in glomerular filtration rate as compared to baseline

Time frame: Day 2

Contrast induced nephropathy?

Time frame: Day 3

Contrast induced nephropathy?

Time frame: Day 7

Change in creatinemia

The brute change in creatinemia between baseline and Day 2

Time frame: baseline versus Day 2

Change in creatinemia

The brute change in creatinemia between baseline and Day 3

Time frame: baseline versus Day 3

Change in creatinemia

The brute change in creatinemia between baseline and Day 7

Time frame: baseline versus Day 7

% Change in creatinemia

% change in creatinemia between baseline and Day 2

Time frame: baseline versus Day 2

% Change in creatinemia

% change in creatinemia between baseline and Day 3

Time frame: baseline versus Day 3

% Change in creatinemia

% change in creatinemia between baseline and Day 7

Time frame: baseline versus Day 7

Change in glomerular filtration rate compared to baseline

Change in glomerular filtration (MDRD; ml/min/1.73m\^2) rate compared to baseline

Time frame: baseline versus Day 2

Change in glomerular filtration rate compared to baseline

Change in glomerular filtration (MDRD; ml/min/1.73m\^2) rate compared to baseline

Time frame: baseline versus Day 3

Change in glomerular filtration rate compared to baseline

Change in glomerular filtration (MDRD; ml/min/1.73m\^2) rate compared to baseline

Time frame: baseline versus Day 7

Quantity of contrast material injected / glomerular filtration rate

Time frame: Day 0 - just after coronarography

Quantity of iodine injected / glomerular filtration rate

Time frame: Day 0, just after coronarography

Hemodialysis necessary?

Was hemodialysis required for the patient? yes/no

Time frame: Day 7

Mortality

The patient passed away during the study. yes/no

Time frame: Day 7

Change in serum ngal

The change in serum ngal (neutrophil gelatinase associated lipocalin) between baseline and 4 hours after the injection of contrast material.

Time frame: baseline (just before coronarography) versus 4 hours after contrast injection