Short-Stay Intensive Care for Coronary Artery Bypass Patients

Coronary Artery Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707044
• Other study ID #: MEC 01-039
• Secondary ID: 00106 (CVZ)
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2008
• Last updated: February 22, 2017
• Start date: January 2001
• Est. completion date: May 2004

Study information

• Verified date: June 2008
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: May 2004
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Bypass

Intervention

Procedure:
• Control group (usual care)
control group, care as usual, 24 hours intensive care stay
• Short-Stay Intensive Care treatment (SSIC)
Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Dutch Health Care Insurance Board (nr: 00106), Amstelveen, The Netherlands

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensive Care (IC) readmissions		one month postoperative
Secondary	total hospital stay, total hospital costs, postoperative morbidity and mortality		one month
Secondary	generic and disease specific Quality of Life (QoL)		one year postoperative