Short-Stay Intensive Care for Coronary Artery Bypass Patients

Phase 3

Completed

• Conditions: Coronary Artery Bypass
• Interventions: Procedure: Short-Stay Intensive Care treatment (SSIC); Procedure: Control group (usual care)

• Registration Number: NCT00707044
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2003-10
• Study Completion: 2004-05
• Status Verified: 2008-06
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-06-30
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 597

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Short-Stay Intensive Care treatment (SSIC)	Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment
B	Control group (usual care)	control group, care as usual, 24 hours intensive care stay

Primary Outcome Measures

Name	Time	Method
Intensive Care (IC) readmissions	one month postoperative

Secondary Outcome Measures

Name	Time	Method
total hospital stay, total hospital costs, postoperative morbidity and mortality	one month
generic and disease specific Quality of Life (QoL)	one year postoperative

Trial Locations

Locations (1)

University Hospital Maastricht; 🇳🇱 Maastricht, Netherlands