Short-Stay Intensive Care for Coronary Artery Bypass Patients

Study Overview
=================
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.

Official Title
-----------------
Short-Stay Intensive Care for Coronary Artery Bypass Patients,Development of a Guideline for Giving Adequate Care on the Cardiosurgical Intensive Care

Conditions
-----------------
Coronary Artery Bypass

Intervention / Treatment
-----------------
* Procedure: Control group (usual care)
* Procedure: Short-Stay Intensive Care treatment (SSIC)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment | Procedure: Short-Stay Intensive Care treatment (SSIC)<br>* Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment<br>|
| Active Comparator: B<br>control group, care as usual, 24 hours intensive care stay | Procedure: Control group (usual care)<br>* control group, care as usual, 24 hours intensive care stay<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care (IC) readmissions |  | one month postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total hospital stay, total hospital costs, postoperative morbidity and mortality |  | one month | 
| generic and disease specific Quality of Life (QoL) |  | one year postoperative |