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Short-Stay Intensive Care for Coronary Artery Bypass Patients

This study has been completed.
Sponsor:
Collaborator:
Dutch Health Care Insurance Board (nr: 00106), Amstelveen, The Netherlands
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00707044
First received: June 26, 2008
Last updated: June 27, 2008
Last verified: June 2008
History of Changes
  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 3

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

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: A
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
Active Comparator: B
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
Dutch Health Care Insurance Board (nr: 00106), Amstelveen, The Netherlands
Investigators
Principal Investigator: Ghislaine van Mastrigt, Msc Maastricht University Medical Center
  More Information

Publications:

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

ClinicalTrials.gov processed this record on May 16, 2013