BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.
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ClinicalTrials.gov Identifier: NCT00252200 |
Recruitment Status
:
Completed
First Posted
: November 11, 2005
Last Update Posted
: September 23, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Kidney Failure | Drug: Neseritide | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery. |
Study Start Date : | March 2003 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | October 2007 |

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Drug: Neseritide
- Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula [ Time Frame: 72 hours post op ]
- Number of patients requiring dialysis during the hospitalization [ Time Frame: before hospital discharge ]
- Plasma aldosterone levels at 12 hours and 24 hours [ Time Frame: 12 hours and 24 hours postoperatively ]
- Total time on ventilator, ICU length of stay, total length of stay in hospital [ Time Frame: total length of hospital stay ]
- pre and postoperative diuretic dose used [ Time Frame: pre operative and postoperate ]
- Need or absence of need for inotropic support in the 72 hour perioperative period [ Time Frame: 72 hours perioperative ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients > 18 years old, undergoing cardiac surgery requiring cardiopulmonary bypass with baseline creatinine clearance < 50 ml/min and who are not dialysis dependent.
Exclusion criteria:
- Cardiogenic shock or hypotension with systolic BP < 90 mmHg.
- Patients with acute or chronic aortic dissection.
- Patients who are enrolled in other studies that have an effect the renal function.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252200
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Horng H. Chen, M.D. | Mayo Clinic |
Responsible Party: | Horng H. Chen, Mayo Clinic Rochester |
ClinicalTrials.gov Identifier: | NCT00252200 History of Changes |
Other Study ID Numbers: |
621-03 |
First Posted: | November 11, 2005 Key Record Dates |
Last Update Posted: | September 23, 2009 |
Last Verified: | September 2009 |
Additional relevant MeSH terms:
Renal Insufficiency Acute Kidney Injury Kidney Diseases Urologic Diseases |
Natriuretic Peptide, Brain Natriuretic Agents Physiological Effects of Drugs |