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| Name | Class |
|---|---|
| Centre Hospitalier de Dieppe | UNKNOWN |
| Centre Hospitalier d'Abbeville | OTHER |
| Centre Hospitalier de Laon | UNKNOWN |
| University Hospital, Caen |
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Sepsis is the most common cause of acute kidney injury (AKI) in critically ill patients and is associated with a high mortality rate. Currently there is no available specific treatment to prevent or treat AKI in this setting. Many experimental and clinical data suggest that Nicotinamide, a safe and inexpensive vitamin, could be effective to prevent major adverse kidney events during septic shock. The main objective of the study is to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care. A 15% reduction in the incidence of major renal adverse events at day 30 is expected in the "Nicotinamide" group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin B3 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide treatment | Drug | Nicotinamide (500 mg) will be mixed in 50 ml of 0.9% saline and administered intravenously every 12 h for a total of 72 h. |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients meeting one or more criteria for MAKE30 | MAKE30 is : in-hospital mortality, receipt of new RRT, or persistent renal dysfunction defined as a final inpatient serum creatinine value ≥2 time baseline serum creatinine | 3 years after study start |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80480 | France |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| OTHER |
| Centre Hospitalier de Cherbourg | UNKNOWN |
| University Hospital, Rouen | OTHER |
| Centre Hospitalier de Roubaix | OTHER |
| Centre Hospitalier de Bethune | NETWORK |
| Hôpital Saint Philibert, Lomme | UNKNOWN |
| Tourcoing Hospital | OTHER |
| Centre Hospitalier de Valenciennes | NETWORK |
| Centre Hospitalier Arras | OTHER |
| Centre Hospitalier de Lens | OTHER |
| Centre Hospitalier de Calais | UNKNOWN |
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| placebo treatment | Drug | For the placebo group, an identical volume of 0.9% saline will be administered in the same manner. |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |