Short-Stay Intensive Care for Coronary Artery Bypass Patients

Maastricht University Medical Centre (MUMC)

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Bypass

Treatments: Procedure: Control group (usual care); Procedure: Short-Stay Intensive Care treatment (SSIC)

Study type: Interventional

Funder types: Other

Identifiers

NCT00707044

MEC 01-039

00106 (CVZ)

Details and patient eligibility

About

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.

Enrollment: 597 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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597 participants in 2 patient groups

A

Experimental group

Description:

Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment

Treatment:

Procedure: Short-Stay Intensive Care treatment (SSIC)

B

Active Comparator group

Description:

control group, care as usual, 24 hours intensive care stay

Treatment:

Procedure: Control group (usual care)