Phase 2
N=29
Does Nesiritide Provide Renal Protection
Renal Failure
Bottom Line
View on ClinicalTrials.gov: NCT01440881 ↗Enrolled (actual)
29
Serious AEs
10.3%
Results posted
Mar 2014
Primary outcome: Primary: Measure Neutrophils to Measure Kidney Injury — 5.453; 5.630; 4.508; 4.546 log2 expression
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nesiritide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure Neutrophils to Measure Kidney Injury |
5.453; 5.630; 4.508; 4.546; 5.501; 5.444 | — |
| PRIMARY The Examine and Measure Cytokines to Measure Kidney Injury |
1.750; 1.959; 28.167; 63.930; 33.457; 57.412 | — |
| PRIMARY The Examine and Measure Endothelin-1 to Measure Kidney Injury |
1.778; 1.239; 2.096; 2.283; 1.670; 2.068 | — |
| PRIMARY The Examine and Measure Urinary NGAL to Measure Kidney Injury |
124.566; 33.766 | — |
Summary
This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing surgery on their aortic arch, ascending aorta, or having aortic valve or mitral valve surgery
- Baseline MDRD (modification of diet in renal disease) calculated GFR (Glomerular Filtration Rate) 30-90 ml/min.
- Signed Informed Consent
Exclusion Criteria
- Age 80
- Ejection Fraction <30%.
- Presence of endocarditis or other infection.
- Presence or anticipated use of an intra-aortic balloon pump.
- History of an organ transplant.
- History of an adverse reaction to nesiritide.
- Surgery performed without cardiopulmonary bypass.
- Receiving Aprotinin
- Dopamine administered in doses <5 mcg /kg min.
- Women of child bearing potential or pregnant or breastfeeding.
- Participation in any other investigational trial
- Jehovah Witness
- Bleeding Disorder
- Active Endocarditis
Data sourced from ClinicalTrials.gov (NCT01440881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.