Short-Stay Intensive Care for Coronary Artery Bypass Patients - Full Text View

Sponsors and Collaborators:	Maastricht University Medical Center Dutch Health Care Insurance Board (nr: 00106), Amstelveen, The Netherlands
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00707044

Purpose

Objective: To evaluate the safety and cost-effectiveness of Short Stay Intensive Care (SSIC) treatment for low-risk coronary artery bypass patients Design: Randomized clinical equivalence trial Setting: University Hospital Maastricht, the Netherlands Patients: low-risk coronary artery bypass patients Interventions: 600 patients were randomly assigned to undergo either SSIC treatment (8 hours Intensive Care) or control treatment (care as usual, overnight Intensive Care).

Measurements: The primary outcome measures were Intensive Care (IC) readmissions and total hospital stay. The secondary outcome measures were total hospital costs, Quality of Life (QoL), postoperative morbidity and mortality. Hospital costs consisted of the cost of hospital admission(s) and outpatient costs.

Condition	Intervention	Phase
Coronary Artery Bypass	Procedure: Control group (usual care) Procedure: Short-Stay Intensive Care treatment (SSIC)	Phase III

MedlinePlus related topics: Coronary Artery Bypass Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Single Group Assignment, Safety/Efficacy Study
Official Title:	Short-Stay Intensive Care for Coronary Artery Bypass Patients,Development of a Guideline for Giving Adequate Care on the Cardiosurgical Intensive Care

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

Intensive Care (IC) readmissions [ Time Frame: one month postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

total hospital stay, total hospital costs, postoperative morbidity and mortality [ Time Frame: one month ] [ Designated as safety issue: No ]
generic and disease specific Quality of Life (QoL) [ Time Frame: one year postoperative ] [ Designated as safety issue: No ]

Enrollment:	597
Study Start Date:	January 2001
Study Completion Date:	May 2004
Primary Completion Date:	October 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment	Procedure: Short-Stay Intensive Care treatment (SSIC) Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment
B: Active Comparator control group, care as usual, 24 hours intensive care stay	Procedure: Control group (usual care) control group, care as usual, 24 hours intensive care stay

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Coronary artery bypass patients

Exclusion Criteria:

age older than 78 years,
ejection fraction of less than 30%
stage 3 obesity (BMI>40kg/m2)
haemodialysis (kidney replacing therapy)
pulmonary hypertension (systolic <40mmHg)
recent CVA (<1month)
recent myocardial infarction (<24hours)
cardiogenic shock, (systolic blood pressure<80mmHg,
central filling pressure>20mmHg,
cardiac index<1.8 litres/minute/m2),
need for inotropic therapy (>5mg/mcg/min. dopamine or dobutamine)
ongoing infarction (a significant increase of enzyme "CKMB" within 4 hours before surgery)
the need for intra-aortic balloon pump
inability to give informed consent
inability to speak/ read/ understand the Dutch language
patients who had emergency surgery.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707044

Locations

Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202AZ

Sponsors and Collaborators

Maastricht University Medical Center

Dutch Health Care Insurance Board (nr: 00106), Amstelveen, The Netherlands

Investigators

Principal Investigator:

Ghislaine van Mastrigt, Msc

Maastricht University Medical Center

More Information

Publications of Results:

van Mastrigt GA, Heijmans J, Severens JL, Fransen EJ, Roekaerts P, Voss G, Maessen JG. Short-stay intensive care after coronary artery bypass surgery: randomized clinical trial on safety and cost-effectiveness. Crit Care Med. 2006 Jan;34(1):65-75.

Responsible Party:	Dutch Health Care Insurance Board ( Mr. M. van Essen )
Study ID Numbers:	MEC 01-039, 00106 (CVZ)
Study First Received:	June 26, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00707044
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on January 16, 2009