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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.
This is a randomized, double-blinded, placebo-controlled trial to evaluate fenoldopam and N-acetylcysteine (NAC) individually, and together, as renal protective agents for patients with renal insufficiency undergoing heart surgery. Subjects have chronic renal insufficiency with creatinine clearance (CrCl) \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC | Experimental | N-acetylcysteine started day prior to surgery, continued through night of surgery |
|
| fenoldopam | Experimental | fenoldopam started at surgery continued for 24 hours |
|
| NAC and fenoldopam | Experimental | Both N-acetylcysteine and fenoldopam as above |
|
| Control | Placebo Comparator | Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug |
|
| |
| fenoldopam |
| Measure | Description | Time Frame |
|---|---|---|
| Length of post-operative hospital stay | 30-day | |
| Length of post-operative critical care stay | 30-day | |
| Creatinine clearance post-operative days 3, 14, and nadir | 14 day |
| Measure | Description | Time Frame |
|---|---|---|
| Days to post-operative creatinine clearance nadir | 14 day | |
| Intraoperative and post-operative pressor use (pressor-hours) | 48 hour | |
| Hospital costs |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda F Barr, MD | Pulmonary and Critical Care Assoc. of Baltimore | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18434903 | Result | Barr LF, Kolodner K. N-acetylcysteine and fenoldopam protect the renal function of patients with chronic renal insufficiency undergoing cardiac surgery. Crit Care Med. 2008 May;36(5):1427-35. doi: 10.1097/CCM.0b013e31816f48ba. | |
| 39607014 | Derived | Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D018818 | Fenoldopam |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Drug |
|
|
| 30-day |
| Mortality | 30-day |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |