A Phase 3 interventional study of Hydration strategy using saline and Hydration strategy using sodium bicarbonate in Acute Kidney Injury and Renal Insufficiency, sponsored by Centre Hospitalier Universitaire de Nīmes. Terminated at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-22.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Phase 3, Interventional, and Prevention
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 9 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
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Exclusion Criteria:
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
Drug: Hydration strategy using sodium bicarbonate · Procedure: 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
Drug: Hydration strategy using saline · Procedure: 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
Drug: Hydration strategy using sodium bicarbonate · Drug: L-carnitine · Procedure: 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
Drug: Hydration strategy using saline · Drug: L-carnitine · Procedure: Coronarography
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.
Also known as: Sodium chloride hydration
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.
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.
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.
Change in glomerular filtration rate
The change in MDRD glomerular filtration rate before coronarography, and 48 hours after the injection of contrast material.
Time frame: baseline versus 48 hours after contrast injection
Contrast induced nephropathy?
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
Time frame: Day 2
Contrast induced nephropathy?
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
Time frame: Day 3
Contrast induced nephropathy?
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
Time frame: Day 7
Change in creatinemia
The brute change in creatinemia between baseline and Day 2
Time frame: baseline versus Day 2
Change in creatinemia
The brute change in creatinemia between baseline and Day 3
Time frame: baseline versus Day 3
Change in creatinemia
The brute change in creatinemia between baseline and Day 7
Time frame: baseline versus Day 7
% Change in creatinemia
% change in creatinemia between baseline and Day 2
Time frame: baseline versus Day 2
% Change in creatinemia
% change in creatinemia between baseline and Day 3
Time frame: baseline versus Day 3
% Change in creatinemia
% change in creatinemia between baseline and Day 7
Time frame: baseline versus Day 7
Change in glomerular filtration rate compared to baseline
Change in glomerular filtration (MDRD; ml/min/1.73m\^2) rate compared to baseline
Time frame: baseline versus Day 2
Change in glomerular filtration rate compared to baseline
Change in glomerular filtration (MDRD; ml/min/1.73m\^2) rate compared to baseline
Time frame: baseline versus Day 3
Change in glomerular filtration rate compared to baseline
Change in glomerular filtration (MDRD; ml/min/1.73m\^2) rate compared to baseline
Time frame: baseline versus Day 7
Quantity of contrast material injected / glomerular filtration rate
Time frame: Day 0 - just after coronarography
Quantity of iodine injected / glomerular filtration rate
Time frame: Day 0, just after coronarography
Hemodialysis necessary?
Was hemodialysis required for the patient? yes/no
Time frame: Day 7
Mortality
The patient passed away during the study. yes/no
Time frame: Day 7
Change in serum ngal
The change in serum ngal (neutrophil gelatinase associated lipocalin) between baseline and 4 hours after the injection of contrast material.
Time frame: baseline (just before coronarography) versus 4 hours after contrast injection
This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nīmes