Clinical trial NCT01786824: Preventing Contrast-induced Nephropathy: Evaluating Hydration Strategies and L-carnitine Administration
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Kidney Injury
Renal Insufficiency
Keywords: contrast induced nephropathy
hydration strategy
L-carnitine
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Change in glomerular filtration rate
timeFrame: baseline versus 48 hours after contrast injection
Secondary outcomes:
measure: Contrast induced nephropathy?
timeFrame: Day 2
measure: Contrast induced nephropathy?
timeFrame: Day 3
measure: Contrast induced nephropathy?
timeFrame: Day 7
measure: Change in creatinemia
timeFrame: baseline versus Day 2
measure: Change in creatinemia
timeFrame: baseline versus Day 3
measure: Change in creatinemia
timeFrame: baseline versus Day 7
measure: % Change in creatinemia
timeFrame: baseline versus Day 2
measure: % Change in creatinemia
timeFrame: baseline versus Day 3
measure: % Change in creatinemia
timeFrame: baseline versus Day 7
measure: Change in glomerular filtration rate compared to baseline
timeFrame: baseline versus Day 2
measure: Change in glomerular filtration rate compared to baseline
timeFrame: baseline versus Day 3
measure: Change in glomerular filtration rate compared to baseline
timeFrame: baseline versus Day 7
measure: Quantity of contrast material injected / glomerular filtration rate
timeFrame: Day 0 - just after coronarography
measure: Quantity of iodine injected / glomerular filtration rate
timeFrame: Day 0, just after coronarography
measure: Hemodialysis necessary?
timeFrame: Day 7
measure: Mortality
timeFrame: Day 7
measure: Change in serum ngal
timeFrame: baseline (just before coronarography) versus 4 hours after contrast injection
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
city: Angers
country: France
facility: CHU d'Angers - Hôtel-Dieu
city: Avignon
country: France
facility: CH d'Avignon - Centre Hospitalier Henri Duffaut
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Perpignan
country: France
facility: CH de Perpignan - Hôpital Saint Jean
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Pascal Reboul, MD
role: PRINCIPAL_INVESTIGATOR
References: