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| Name | Class |
|---|---|
| Scios, Inc. | INDUSTRY |
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Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.
This is a randomized, double-blind, placebo controlled study of low dose nesiritide to prevent renal insufficiency after cardiopulmonary bypass surgery. Patients included are those with greater than mild renal insufficiency preoperatively as defined by having a creatinine clearance of less than 50 mL/minute determined by the Cockroft-Gault formula. The infusion of nesiritide (BNP) 0.005 mcg/Kg/minute or placebo begins 1 hour before surgery and runs for 24 hours started after the induction of anesthesia prior to cardiopulmonary bypass.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neseritide | Drug | Dose of Nesiritide infusion will be 0.005 ug/Kg/min |
|
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula | 72 hours post op |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients requiring dialysis during the hospitalization | before hospital discharge | |
| Plasma aldosterone levels at 12 hours and 24 hours | 12 hours and 24 hours postoperatively | |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horng H. Chen, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D020097 | Natriuretic Peptide, Brain |
| ID | Term |
|---|---|
| D045265 | Natriuretic Peptides |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Total time on ventilator, ICU length of stay, total length of stay in hospital |
| total length of hospital stay |
| pre and postoperative diuretic dose used | pre operative and postoperate |
| Need or absence of need for inotropic support in the 72 hour perioperative period | 72 hours perioperative |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |