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CompletedNCT00252200Updated Sep 23, 2009

BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.

A Phase 1/2 interventional study of Neseritide in Acute Kidney Failure, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-09-23.

Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.

Read the detailed description

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.

02

Conditions studied

  • Acute Kidney Failure
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 40 is close to the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
40 participants (actual)

Interventions

  • DrugNeseritide

    Dose of Nesiritide infusion will be 0.005 ug/Kg/min

    Also known as: BNP, Nesiritide

06

What researchers measure

Primary outcomes

  1. Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula

    Time frame: 72 hours post op

Secondary outcomes

  1. Number of patients requiring dialysis during the hospitalization

    Time frame: before hospital discharge

  2. Plasma aldosterone levels at 12 hours and 24 hours

    Time frame: 12 hours and 24 hours postoperatively

  3. Total time on ventilator, ICU length of stay, total length of stay in hospital

    Time frame: total length of hospital stay

  4. pre and postoperative diuretic dose used

    Time frame: pre operative and postoperate

  5. Need or absence of need for inotropic support in the 72 hour perioperative period

    Time frame: 72 hours perioperative

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00252200
Lead sponsor
Mayo Clinic
Collaborators
Scios, Inc.
First posted
Nov 11, 2005
Start date
Mar 2003
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Sep 23, 2009

Study contacts

Horng H. Chen, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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