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

Acute Kidney Injury Clinical Trial

— CinBiCarn  

Official title:

Preventing Nephropathy Induced by Iodinated Contrast Media in Patients With Renal Impairment: a Randomized Trial Evaluating the Effectiveness of Two Hydration Strategies and L-carnitine Administration

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01786824
• Other study ID #: LOCAL/2012/PR-03
• Secondary ID: 2012-004134-42
• Status: Terminated
• Phase: Phase 3
• First received: February 6, 2013
• Last updated: March 21, 2016
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Diseases
• Renal Insufficiency

Intervention

Drug:
• 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.
• 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.
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
France	CHU d'Angers - Hôtel-Dieu	Angers
France	CH d'Avignon - Centre Hospitalier Henri Duffaut	Avignon
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard
France	CH de Perpignan - Hôpital Saint Jean	Perpignan

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glomerular filtration rate	The change in MDRD glomerular filtration rate before coronarography, and 48 hours after the injection of contrast material.	baseline versus 48 hours after contrast injection	Yes
Secondary	Contrast induced nephropathy?	The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following: a >= 25% increase in creatinemia as compared to baseline; an absolute increase >= 44 µmol/L in creatinemia as compared to baseline; a decrease >= 25% in glomerular filtration rate as compared to baseline	Day 2	Yes
Secondary	Contrast induced nephropathy?	The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following: a >= 25% increase in creatinemia as compared to baseline; an absolute increase >= 44 µmol/L in creatinemia as compared to baseline; a decrease >= 25% in glomerular filtration rate as compared to baseline	Day 3	Yes
Secondary	Contrast induced nephropathy?	The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following: a >= 25% increase in creatinemia as compared to baseline; an absolute increase >= 44 µmol/L in creatinemia as compared to baseline; a decrease >= 25% in glomerular filtration rate as compared to baseline	Day 7	Yes
Secondary	Change in creatinemia	The brute change in creatinemia between baseline and Day 2	baseline versus Day 2	Yes
Secondary	Change in creatinemia	The brute change in creatinemia between baseline and Day 3	baseline versus Day 3	Yes
Secondary	Change in creatinemia	The brute change in creatinemia between baseline and Day 7	baseline versus Day 7	Yes
Secondary	% Change in creatinemia	% change in creatinemia between baseline and Day 2	baseline versus Day 2	Yes
Secondary	% Change in creatinemia	% change in creatinemia between baseline and Day 3	baseline versus Day 3	Yes
Secondary	% Change in creatinemia	% change in creatinemia between baseline and Day 7	baseline versus Day 7	Yes
Secondary	Change in glomerular filtration rate compared to baseline	Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline	baseline versus Day 2	Yes
Secondary	Change in glomerular filtration rate compared to baseline	Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline	baseline versus Day 3	Yes
Secondary	Change in glomerular filtration rate compared to baseline	Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline	baseline versus Day 7	Yes
Secondary	Quantity of contrast material injected / glomerular filtration rate		Day 0 - just after coronarography	No
Secondary	Quantity of iodine injected / glomerular filtration rate		Day 0, just after coronarography	No
Secondary	Hemodialysis necessary?	Was hemodialysis required for the patient? yes/no	Day 7	Yes
Secondary	Mortality	The patient passed away during the study. yes/no	Day 7	Yes
Secondary	Change in serum ngal	The change in serum ngal (neutrophil gelatinase associated lipocalin) between baseline and 4 hours after the injection of contrast material.	baseline (just before coronarography) versus 4 hours after contrast injection	Yes