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

NCT ID: NCT01786824

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Bicarbonate

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

Group Type: EXPERIMENTAL

Hydration strategy using sodium bicarbonate

Intervention Type: 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.

Coronarography

Intervention Type: 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.

Saline

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

Group Type: ACTIVE_COMPARATOR

Hydration strategy using saline

Intervention Type: 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.

Coronarography

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Hydration strategy using sodium bicarbonate

Intervention Type: 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.

L-carnitine

Intervention Type: 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.

Coronarography

Intervention Type: 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.

Saline + L-carnitine

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

Group Type: EXPERIMENTAL

Hydration strategy using saline

Intervention Type: 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.

L-carnitine

Intervention Type: 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.

Coronarography

Intervention Type: 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.

Interventions

Hydration strategy using saline

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.

Intervention Type: DRUG

Hydration strategy using sodium bicarbonate

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.

Intervention Type: DRUG

L-carnitine

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.

Intervention Type: DRUG

Coronarography

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.

Intervention Type: PROCEDURE

Other Intervention Names

Sodium chloride hydration

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal Reboul, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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

Countries

France

Other Identifiers

2012-004134-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LOCAL/2012/PR-03

Identifier Type: -

Identifier Source: org_study_id