Preventing Contrast-induced Nephropathy: Evaluating Hydration Strategies and L-carnitine Administration
- Conditions
- Renal InsufficiencyAcute Kidney Injury
- Interventions
- Drug: Hydration strategy using sodium bicarbonateDrug: Hydration strategy using salineProcedure: Coronarography
- Registration Number
- NCT01786824
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Bicarbonate Hydration strategy using sodium bicarbonate 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 Bicarbonate Coronarography 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 Saline Coronarography 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 Bicar + L-Carnitine Coronarography 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 Saline Hydration strategy using saline 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 Bicar + L-Carnitine Hydration strategy using sodium bicarbonate 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 Saline + L-carnitine Hydration strategy using saline 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 Saline + L-carnitine Coronarography 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 Bicar + L-Carnitine L-carnitine 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 Saline + L-carnitine L-carnitine 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
- Primary Outcome Measures
Name Time Method Change in glomerular filtration rate baseline versus 48 hours after contrast injection The change in MDRD glomerular filtration rate before coronarography, and 48 hours after the injection of contrast material.
- Secondary Outcome Measures
Name Time Method Hemodialysis necessary? Day 7 Was hemodialysis required for the patient? yes/no
Mortality Day 7 The patient passed away during the study. yes/no
% Change in creatinemia baseline versus Day 7 % change in creatinemia between baseline and Day 7
Quantity of contrast material injected / glomerular filtration rate Day 0 - just after coronarography Change in creatinemia baseline versus Day 7 The brute change in creatinemia between baseline and Day 7
Change in glomerular filtration rate compared to baseline baseline versus Day 7 Change in glomerular filtration (MDRD; ml/min/1.73m\^2) rate compared to baseline
Contrast induced nephropathy? Day 7 The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following:
1. a \>= 25% increase in creatinemia as compared to baseline
2. an absolute increase \>= 44 µmol/L in creatinemia as compared to baseline
3. a decrease \>= 25% in glomerular filtration rate as compared to baselineQuantity of iodine injected / glomerular filtration rate Day 0, just after coronarography Change in serum ngal baseline (just before coronarography) versus 4 hours after contrast injection The change in serum ngal (neutrophil gelatinase associated lipocalin) between baseline and 4 hours after the injection of contrast material.
Trial Locations
- Locations (5)
CHU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, Gard, France
CHU de Montpellier - Hôpital Lapeyronie
🇫🇷Montpellier, France
CHU d'Angers - Hôtel-Dieu
🇫🇷Angers, France
CH d'Avignon - Centre Hospitalier Henri Duffaut
🇫🇷Avignon, France
CH de Perpignan - Hôpital Saint Jean
🇫🇷Perpignan, France