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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass
• Intervention / Treatment: Procedure: Short-Stay Intensive Care treatment (SSIC); Procedure: Control group (usual care)

• Study Type: Interventional
• Enrollment (Actual): 597
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6202AZ
    • University Hospital Maastricht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment	Procedure: Short-Stay Intensive Care treatment (SSIC); Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment
Active Comparator: B; control group, care as usual, 24 hours intensive care stay	Procedure: Control group (usual care); control group, care as usual, 24 hours intensive care stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intensive Care (IC) readmissions	one month postoperative

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Dutch Health Care Insurance Board (nr: 00106), Amstelveen, The Netherlands
• Investigators: Principal Investigator: Ghislaine van Mastrigt, Msc, Maastricht University Medical Center

Publications and helpful links

General Publications

• van Mastrigt GA, Heijmans J, Severens JL, Fransen EJ, Roekaerts P, Voss G, Maessen JG. Short-stay intensive care after coronary artery bypass surgery: randomized clinical trial on safety and cost-effectiveness. Crit Care Med. 2006 Jan;34(1):65-75. doi: 10.1097/01.ccm.0000191266.72652.fa.

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): October 1, 2003
• Study Completion (Actual): May 1, 2004

Study Registration Dates

• First Submitted: June 26, 2008
• First Submitted That Met QC Criteria: June 27, 2008
• First Posted (Estimate): June 30, 2008

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: MEC 01-039; 00106 (CVZ)