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Completed

NCT Number: NCT00707044

Short-Stay Intensive Care for Coronary Artery Bypass Patients

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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Key information

Conditions

Coronary Artery Bypass

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Maastricht

Maastricht, 6202AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control group (usual care)

Procedure

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

Short-Stay Intensive Care treatment (SSIC)

Procedure

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

Primary outcomes

  1. Intensive Care (IC) readmissions

    Time frame: one month postoperative

Secondary outcomes

  1. total hospital stay, total hospital costs, postoperative morbidity and mortality

    Time frame: one month

  2. generic and disease specific Quality of Life (QoL)

    Time frame: one year postoperative

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Dutch Health Care Insurance Board

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2003
Study completion
2004
First posted
Jun 30, 2008
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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