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Short-Stay Intensive Care for Coronary Artery Bypass Patients

NCT00707044 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 597

Last updated 2017-02-24

No results posted yet for this study

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.

Conditions

  • Coronary Artery Bypass

Interventions

PROCEDURE

Control group (usual care)

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

PROCEDURE

Short-Stay Intensive Care treatment (SSIC)

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

Sponsors & Collaborators

  • Dutch Health Care Insurance Board (nr: 00106), Amstelveen, The Netherlands

    collaborator UNKNOWN

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Ghislaine van Mastrigt, Msc · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2003-10-31
Completion
2004-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00707044 on ClinicalTrials.gov