Perioperative Treatment of Patients Undergoing Coronary Artery Bypass Surgery - Full Text View

Sponsored by:	Scios, Inc.
Information provided by:	Scios, Inc.
ClinicalTrials.gov Identifier:	NCT00090792

Purpose

The purpose of this study is to assess the effects of Natrecor in the perioperative setting for patients undergoing coronary artery bypass graft (CABG) requiring cardiopulmonary bypass (CPB).

The objectives of particular interest are:

Effect on renal function
Effect on hemodynamics
Need for interventions (inotropes, vasopressors, vasodilation)
Clinical outcomes (including length of stay in ICU/CCU, hospitals, time on CPB, and time to extubation).

Condition	Intervention	Phase
Myocardial Ischemia Coronary Artery Bypass Surgery	Drug: Natrecor (nesiritide)A014	Phase II

MedlinePlus related topics: Coronary Artery Bypass Surgery Surgery

Drug Information available for: Nesiritide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate Nesiritide Infusion, Initiated Post-Induction of Anesthesia, in the Management of Coronary Artery Bypass Graft (CABG) Patients Requiring Cardiopulmonary Bypass (CPB)

Further study details as provided by Scios, Inc.:

Primary Outcome Measures:

Effect on renal function hemodynamics need for interventions and clinical outcomes.

Secondary Outcome Measures:

Time to extubation, time to discharge from ICU/CCU and hospital, 24 hrs urine output on each postoperative day until discharge from ICU/CCU, time on CPB and AE.

Estimated Enrollment:	300
Study Start Date:	October 2003
Estimated Study Completion Date:	June 2005

Detailed Description:

Perioperative treatment of patients undergoing coronary artery bypass surgery.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age> 18 years.
NYHA class II-IV CHF.
Presenting for coronary artery bypass graft (CABG) with or without mitral valve repair or replacement.
Planned utilization of CPB
Documentation of left ventricular ejection fraction (LVEF)<40% measured by nuclear scan, ECHO, ventriculogram, within 30 days prior to surgery.

Exclusion Criteria:

Planned aortic valve replacement or repair.
Ongoing or chronic dialysis.
Documented bacterial/fungal/viral infection requiring administration of IV antibiotics within 7 days prior to surgery.
Pulmonary disease (COPD), asthma, or other conditions that have required inpatient medical or surgical treatment within 60 days prior to surgery.
Treatment exclusion criteria-obtained after anesthesia induction and before chest incision prior to the start of study drug.
Documented or suspected low cardiac filling pressures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090792

Show 66 Study Locations

Sponsors and Collaborators

Scios, Inc.

More Information

No publications provided

Study ID Numbers:	Natrecor A014
Study First Received:	September 3, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00090792 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Anesthetics
Cardiovascular Agents
Ischemia

Additional relevant MeSH terms:

Natriuretic Peptide, Brain
Heart Diseases
Pathologic Processes
Natriuretic Agents
Therapeutic Uses
Myocardial Ischemia

Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents
Ischemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009