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| ID | Type | Description | Link |
|---|---|---|---|
| 141521A-11 | Other Identifier | ANSM | |
| 2014-005146-22 | EudraCT Number |
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departure of the coordinating investigator from another institution
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Acute kidney injury (AKI) is a common disorder and associated with high morbidity and mortality. However, distinguishing transient AKI from persistent AKI may help in individualizing treatment and limit short and long term consequences of AKI. Previous studies suggested usual urinary indices to perform poorly for separating transient from persistent AKI in an unselected population of critically ill patients. The recent KDIGO (Kidney Disease Improving Global Outcomes) guidelines underlined the need for additional strategies in estimating renal short term prognosis.
Recently, a Furosemide stress test (FST) was validated in a cohort of unselected critically ill patients. This stress test performance was found to be good in predicting capacity to identify those patients that will progress to advanced stage AKI. Additionally, FST performance was higher than those of usual renal biomarker. The limited sample size of this preliminary study however precluded adjustment for usual confounders including oliguria.
The primary objective of this study is to assess diagnostic performance of FST in differentiating transient and persistent AKI. Secondary objectives are to assess diagnostic performance of FST in predicting need for renal replacement therapy, and to confirm FST results after adjustment for confounders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furosemide stress test | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | 1.0 mg/kg of intravenous furosemide. In order to minimize the risk of hypovolemia, urine output will be replaced ml for ml with either Ringers lactate or normal saline for six hours after the furosemide stress test. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with renal recovery | day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| natriuresis(mmol/L) | day 0 to day 3 | |
| fractional excretion of sodium(%) | day 0 to day 3 | |
| fractional excretion of urea (%), |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael DARMON, MD PhD | CHU de SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de CLERMONT-FERRAND | Clermont-Ferrand | 63000 | France | |||
| CHU de MONTPELLIER |
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| day 0 to day 3 |
| U/P urea ratio(mg.dl-1/ mg.dl-1) | day 0 to day 3 |
| U/P creatinine ratio (mg.dl-1/ mg.dl-1) | day 0 to day 3 |
| Montpellier |
| 34000 |
| France |
| CHU de SAINT-ETIENNE | Saint-Etienne | 42000 | France |
| CHRU de STRASBOURG | Strasbourg | 67000 | France |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D009846 | Oliguria |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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