Acute Kidney Injury, Renal Insufficiency
Conditions
Keywords
contrast induced nephropathy, hydration strategy, L-carnitine
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.
Interventions
DRUGHydration 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.
DRUGHydration 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.
DRUGL-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.
PROCEDURECoronarography
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.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in creatinemia | baseline versus Day 2 | The brute change in creatinemia between baseline and Day 2 |
| % Change in creatinemia | baseline versus Day 2 | % change in creatinemia between baseline and Day 2 |
| Change in glomerular filtration rate compared to baseline | baseline versus Day 2 | Change in glomerular filtration (MDRD; ml/min/1.73m\^2) rate compared to baseline |
| Quantity of contrast material injected / glomerular filtration rate | Day 0 - just after coronarography | — |
| Contrast induced nephropathy? | Day 2 | 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 baseline |
| 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 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. |
| Quantity of iodine injected / glomerular filtration rate | Day 0, just after coronarography | — |
Countries
France
Outcome results
None listed