NCT00707044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
597

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2008

Completed
Last Updated

February 24, 2017

Status Verified

June 1, 2008

Enrollment Period

2.7 years

First QC Date

June 26, 2008

Last Update Submit

February 22, 2017

Conditions

Coronary Artery Bypass

Outcome Measures

Primary Outcomes (1)

  • Intensive Care (IC) readmissions

    one month postoperative

Secondary Outcomes (2)

  • total hospital stay, total hospital costs, postoperative morbidity and mortality

    one month

  • generic and disease specific Quality of Life (QoL)

    one year postoperative

Study Arms (2)

A

EXPERIMENTAL

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

Procedure: Short-Stay Intensive Care treatment (SSIC)

B

ACTIVE COMPARATOR

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

Procedure: Control group (usual care)

Interventions

Control group (usual care)PROCEDURE

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

B
Short-Stay Intensive Care treatment (SSIC)PROCEDURE

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

A

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary artery bypass patients

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Maastricht

Maastricht, 6202AZ, Netherlands

Location

Related 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. doi: 10.1097/01.ccm.0000191266.72652.fa.

    PMID: 16374158RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ghislaine van Mastrigt, Msc

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2008

First Posted

June 30, 2008

Study Start

January 1, 2001

Primary Completion

October 1, 2003

Study Completion

May 1, 2004

Last Updated

February 24, 2017

Record last verified: 2008-06

Locations

NL(1)