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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004134-42 | EudraCT Number |
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Patient pathway has become infeasible due to pressure for shorter hospital stays. Not enough inclusions.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bicarbonate | Experimental | 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 |
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| Saline | Active Comparator | 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 |
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| Bicar + L-Carnitine | Experimental | 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 |
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| Saline + L-carnitine | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydration strategy using saline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast induced nephropathy? | The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following:
| Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Reboul, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | Gard | 30029 | France | ||
| CHU d'Angers - Hôtel-Dieu |
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| Hydration strategy using sodium bicarbonate | Drug | 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 | Drug | 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. |
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| Coronarography | Procedure | 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. |
|
| Contrast induced nephropathy? | The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following:
| Day 3 |
| Contrast induced nephropathy? | The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following:
| Day 7 |
| Change in creatinemia | The brute change in creatinemia between baseline and Day 2 | baseline versus Day 2 |
| Change in creatinemia | The brute change in creatinemia between baseline and Day 3 | baseline versus Day 3 |
| Change in creatinemia | The brute change in creatinemia between baseline and Day 7 | baseline versus Day 7 |
| % Change in creatinemia | % change in creatinemia between baseline and Day 2 | baseline versus Day 2 |
| % Change in creatinemia | % change in creatinemia between baseline and Day 3 | baseline versus Day 3 |
| % Change in creatinemia | % change in creatinemia between baseline and Day 7 | 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 | 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 | 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 | baseline versus Day 7 |
| Quantity of contrast material injected / glomerular filtration rate | Day 0 - just after coronarography |
| Quantity of iodine injected / glomerular filtration rate | Day 0, just after coronarography |
| Hemodialysis necessary? | Was hemodialysis required for the patient? yes/no | Day 7 |
| Mortality | The patient passed away during the study. yes/no | 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. | baseline (just before coronarography) versus 4 hours after contrast injection |
| Angers |
| 49933 |
| France |
| CH d'Avignon - Centre Hospitalier Henri Duffaut | Avignon | 84902 | France |
| CHU de Montpellier - Hôpital Lapeyronie | Montpellier | 34295 | France |
| CH de Perpignan - Hôpital Saint Jean | Perpignan | 66046 | France |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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