Coronary Artery BypassPhase 3NCT00707044
Short-Stay Intensive Care for Coronary Artery Bypass Patients
A Phase 3 study testing Short-Stay Intensive Care treatment (SSIC) in people with Coronary Artery Bypass, run by Maastricht University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- Short-Stay Intensive Care treatment (SSIC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2001to May 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery bypass patients
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Artery Bypass
- Being tested
- Control group (usual care), Short-Stay Intensive Care treatment (SSIC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group (usual care)Procedure or surgery
control group, care as usual, 24 hours intensive care stay
Short-Stay Intensive Care treatment (SSIC)Procedure or surgery
Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment Receives: Procedure: Short-Stay Intensive Care treatment (SSIC) |
| B | Active comparator | control group, care as usual, 24 hours intensive care stay Receives: Procedure: Control group (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Care (IC) readmissions
Measured: one month postoperative
Secondary outcomes (2)
total hospital stay, total hospital costs, postoperative morbidity and mortality
Measured: one month
generic and disease specific Quality of Life (QoL)
Measured: one year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startJan 2001
- Primary completionOct 2003
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Health Care Insurance Board
- Investigators
- Ghislaine van Mastrigt, Msc, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707044
- Sponsor's protocol ID
- MEC 01-039
- Other IDs
- 00106 (CVZ)
- Status last verified
- Jun 2008
- First submitted
- 26 Jun 2008
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16374158
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Stay Intensive Care for Coronary Artery Bypass Patients,Development of a Guideline for Giving Adequate Care on the Cardiosurgical Intensive Care
- ClinicalTrials.gov ID
- NCT00707044
- Acronym / sponsor ID
- MEC 01-039
- Conditions
- Coronary Artery Bypass
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Health Care Insurance Board
- Study start
- Jan 2001
- Primary completion
- Oct 2003 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Short-Stay Intensive Care treatment (SSIC)Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment |
| B | Active comparator | Procedure: Control group (usual care)control group, care as usual, 24 hours intensive care stay |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Coronary artery bypass patients
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control group (usual care)control group, care as usual, 24 hours intensive care stay | Procedure or surgery | B |
| Short-Stay Intensive Care treatment (SSIC)Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment | Procedure or surgery | A |
Primary outcome
Intensive Care (IC) readmissions
Time frame: one month postoperative
2 secondary outcomes
total hospital stay, total hospital costs, postoperative morbidity and mortality
Time frame: one month
generic and disease specific Quality of Life (QoL)
Time frame: one year postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Results publication: PubMed 16374158van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghislaine van Mastrigt, Msc principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Short-Stay Intensive Care treatment (SSIC) in people with Coronary Artery Bypass, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive Care (IC) readmissions (time frame: one month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00707044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.