Clinical trial NCT00707044: Short-Stay Intensive Care for Coronary Artery Bypass Patients
Official title: Short-Stay Intensive Care for Coronary Artery Bypass Patients,Development of a Guideline for Giving Adequate Care on the Cardiosurgical Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Bypass
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Health Care Insurance Board (nr: 00106), Amstelveen, The Netherlands
First posted: 2008-06-30
Enrollment: 597
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility 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.

Primary outcomes:
measure: Intensive Care (IC) readmissions
timeFrame: one month postoperative
Secondary outcomes:
measure: total hospital stay, total hospital costs, postoperative morbidity and mortality
timeFrame: one month
measure: generic and disease specific Quality of Life (QoL)
timeFrame: one year postoperative
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
Study officials:
affiliation: Maastricht University Medical Center
name: Ghislaine van Mastrigt, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/01.ccm.0000191266.72652.fa.