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

Centre Hospitalier Universitaire de Nīmes

Status and phase: Terminated; Phase 3

Conditions: Acute Kidney Injury; Renal Insufficiency

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01786824

2012-004134-42 (EudraCT Number)

LOCAL/2012/PR-03

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

9 participants in 4 patient groups

Bicarbonate

Experimental group

Description:

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

Treatment:

Procedure: Coronarography

Drug: Hydration strategy using sodium bicarbonate

Saline

Active Comparator group

Description:

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

Treatment:

Drug: Hydration strategy using saline

Procedure: Coronarography

Bicar + L-Carnitine

Experimental group

Description:

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

Treatment:

Drug: L-carnitine

Procedure: Coronarography

Drug: Hydration strategy using sodium bicarbonate

Saline + L-carnitine

Experimental group

Description:

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

Treatment:

Drug: L-carnitine

Drug: Hydration strategy using saline

Procedure: Coronarography