Short-Stay Intensive Care for Coronary Artery Bypass Patients

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00707044

Enrollment

597

Registered

2008-06-30

Start date

2001-01-31

Completion date

2004-05-31

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass

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.

Interventions

PROCEDUREControl group (usual care)

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

PROCEDUREShort-Stay Intensive Care treatment (SSIC)

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 78 Years

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.

Design outcomes

Primary

Measure	Time frame
Intensive Care (IC) readmissions	one month postoperative

Secondary

Measure	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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026