Status:
COMPLETED
Short-Stay Intensive Care for Coronary Artery Bypass Patients
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Dutch Health Care Insurance Board (nr: 00106), Amstelveen, The Netherlands
Conditions:
Coronary Artery Bypass
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
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 Settin...
Eligibility Criteria
Inclusion
- Coronary artery bypass patients
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
597 Patients enrolled
Trial Details
Trial ID
NCT00707044
Start Date
January 1 2001
End Date
May 1 2004
Last Update
February 24 2017
Active Locations (1)
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1
University Hospital Maastricht
Maastricht, Netherlands, 6202AZ