NCT00252200

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 23, 2009

Status Verified

September 1, 2009

Enrollment Period

4.6 years

First QC Date

November 10, 2005

Last Update Submit

September 22, 2009

Conditions

Acute Kidney Failure

Outcome Measures

Primary Outcomes (1)

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

    72 hours post op

Secondary Outcomes (5)

  • 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

  • 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

Interventions

NeseritideDRUG

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

Also known as: BNP, Nesiritide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 18 years old, undergoing cardiac surgery requiring cardiopulmonary bypass with baseline creatinine clearance \< 50 ml/min and who are not dialysis dependent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Horng H. Chen, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 11, 2005

Study Start

March 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

September 23, 2009

Record last verified: 2009-09

Locations

US(1)