Coronary Artery Bypass Graft SurgeryNCT00248885
Peri-Operative Morbidity and Quality of Life After Coronary Artery Bypass Graft (CABG)
A study testing Regulating Mean Arterial Pressure during cardiopulmonary bypass in people with Coronary Artery Bypass Graft Surgery, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
It is the long term objective of this study to preserve or improve the quality of life and to prevent deterioration in physical and mental function following myocardial revascularization among bypass surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery
- What is being tested?
- Regulating Mean Arterial Pressure during cardiopulmonary bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1991to Sep 1994
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients had to be undergoing elective CABG, without concomitant valve or other cardiac surgery.
- Patients also had to be able to perform the neuropsychologic tests, and to provide informed consent.
Who cannot join
- Patients who refused to participate in the study.
- Patients who live too far away from NYC to be able to come back for follow up at six months post-operatively.
- Patients who had either valvular replacement and aortic amd mitral an aneurysm repair, or other cardiothoracic surgery.
- Patients who were unable to complete the neuropsychologic test.
- Patient who were part of another CABG study.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital-Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Peri-Operative Morbidity and Quality of Life After CABG
It is the long term objective of this study to preserve or improve the quality of life and to prevent deterioration in physical and mental function following myocardial revascularization among bypass surgery patients.
Read the detailed description
The objective of this study is to compare the efficacy of two strategies of intra-operative hemodynamic management in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and postoperative deterioration in the patient's quality of life.
- Conditions
- Coronary Artery Bypass Graft Surgery
- Being tested
- Regulating Mean Arterial Pressure during cardiopulmonary bypass
- Keywords
- Coronary artery bypass graft surgery, Perioperative complications, Neurocognitive function, Quality of life, Blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulating Mean Arterial Pressure during cardiopulmonary bypassProcedure or surgery
Also called Mean Arterial Pressure during cardiopulmonary bypass 50-60 mm/Hg (control) vs. 80-100 mm/Hg (experimental)
Patients were randomized to one of two groups. In the first group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. In the second group (High), the goal was to maintain MAP between 80-100 mm Hg. In both groups, CPB flow was held constant at 1.6 L/min/M2 (cool) and 2.4 L/min/M2 (warm) and vasoactive drugs (nitroglycerin or phenylephrine) were used to maintain MAP in the desired range. MAP was controlled in this fashion from the onset of CPB through separation from CPB began.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | In this group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. Receives: Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass |
| 2 | Experimental | In this group (High), the goal was to maintain MAP between 80-100 mm Hg during CPB. Receives: Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac morbidity
Measured: 6-months after surgery
Neurologic morbidity
Measured: 6-months after surgery
Mortality
Measured: 6-months after surgery
Functional status
Measured: 6-months after surgery
Neurocognitive function
Measured: 6-months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startSep 1991
- Study completionSep 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Mary E Charlson, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248885
- Sponsor's protocol ID
- 0001004169 (Formerly 0100-006)
- Status last verified
- Apr 2008
- First submitted
- 3 Nov 2005
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Operative Morbidity and Quality of Life After CABG
- ClinicalTrials.gov ID
- NCT00248885
- Acronym / sponsor ID
- 0001004169 (Formerly 0100-006)
- Conditions
- Coronary Artery Bypass Graft Surgery
- Keywords
- Coronary artery bypass graft surgery, Perioperative complications, Neurocognitive function, Quality of life, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1991
- Study completion
- Sep 1994 (actual)
- First posted
- 4 Nov 2005 (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.
It is the long term objective of this study to preserve or improve the quality of life and to prevent deterioration in physical and mental function following myocardial revascularization among bypass surgery patients.
Detailed description
The objective of this study is to compare the efficacy of two strategies of intra-operative hemodynamic management in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and postoperative deterioration in the patient's quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypassIn this group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. |
| 2 | Experimental | Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypassIn this group (High), the goal was to maintain MAP between 80-100 mm Hg during CPB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients had to be undergoing elective CABG, without concomitant valve or other cardiac surgery.
- Patients also had to be able to perform the neuropsychologic tests, and to provide informed consent.
Key exclusion criteria (5 listed)
- Patients who refused to participate in the study.
- Patients who live too far away from NYC to be able to come back for follow up at six months post-operatively.
- Patients who had either valvular replacement and aortic amd mitral an aneurysm repair, or other cardiothoracic surgery.
- Patients who were unable to complete the neuropsychologic test.
- Patient who were part of another CABG study.
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 |
|---|---|---|
| Regulating Mean Arterial Pressure during cardiopulmonary bypassAlso: Mean Arterial Pressure during cardiopulmonary bypass 50-60 mm/Hg (control) vs. 80-100 mm/Hg (experimental)Patients were randomized to one of two groups. In the first group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. In the second group (High), the goal was to maintain MAP between 80-100 mm Hg. In both groups, CPB flow was held constant at 1.6 L/min/M2 (cool) and 2.4 L/min/M2 (warm) and vasoactive drugs (nitroglycerin or phenylephrine) were used to maintain MAP in the desired range. MAP was controlled in this fashion from the onset of CPB through separation from CPB began. | Procedure or surgery | 1, 2 |
Primary outcome
Cardiac morbidity
Time frame: 6-months after surgery
Neurologic morbidity
Time frame: 6-months after surgery
Mortality
Time frame: 6-months after surgery
Functional status
Time frame: 6-months after surgery
Neurocognitive function
Time frame: 6-months after surgery
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 11 Apr 2008.
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Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
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Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
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Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
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Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
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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.
Mary E Charlson, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regulating Mean Arterial Pressure during cardiopulmonary bypass in people with Coronary Artery Bypass Graft Surgery, run by Weill Medical College of Cornell University at 1 site in United States.
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 2 inclusion and 5 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 11 Apr 2008. 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 United States. 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.
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?
Cardiac morbidity (time frame: 6-months after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2008.