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

What Was Tested

In this phase 3 trial, researchers set out to test L-Carnitine.

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.

The researchers will also test for a potential interaction between these two factors.

It had four arms (groups): Bicarbonate (experimental), Saline (active comparator), Bicar + L-Carnitine (experimental) and Saline + L-carnitine (experimental).

The registry classes the interventions as drug and procedure.

Who Took Part

Enrollment: 9 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: The patient must have given his/her informed and signed consent. 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 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.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: the patient is participating in another study; the patient is in an exclusion period determined by another study; the patient is under judicial protection.

How the Study Was Run

The set-up was randomized, factorial and open-label.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

Nothing was hidden in this open-label L-Carnitine study: the participants and staff both knew the treatment.

It started in 2014-12 with completion listed for 2015-08.

It ran at 5 sites in France (5).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Change in glomerular filtration rate (time frame: baseline versus 48 hours after contrast injection).

It also tracked 17 secondary outcomes, for example Contrast induced nephropathy?, Contrast induced nephropathy?, Contrast induced nephropathy?, Change in creatinemia, Change in creatinemia and Change in creatinemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 9 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.