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

• Status: Terminated
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes
• Treatments: Pharmaceutical Solutions

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)