Short-Stay Intensive Care for Coronary Artery Bypass Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

597 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2004-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

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

Group Type EXPERIMENTAL

Short-Stay Intensive Care treatment (SSIC)

Intervention Type PROCEDURE

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

B

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

Group Type ACTIVE_COMPARATOR

Control group (usual care)

Intervention Type PROCEDURE

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

Interventions

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Control group (usual care)

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

Intervention Type PROCEDURE

Short-Stay Intensive Care treatment (SSIC)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No