Coronary Artery DiseaseNCT00881192
Perioperative Intra-Aortic Balloon Pump (IABP) in Coronary Artery Bypass Grafting (CABG) Operations in Patients With Severely Depressed Left Ventricular Function
A study testing IABP in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by IRCCS Policlinico S. Donato at 2 sites in Italy.
Trial summary
Since its first introduction in humans in 1962, Intra-Aortic Balloon Pump (IABP) is now the most commonly used therapeutic option to support failing heart in cardiac surgery. The main effects of IABP are an increase in diastolic blood pressure and therefore an improvement in coronary perfusion and a reduction of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Grafting
- What is being tested?
- IABP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesItaly
- Study dates
- Apr 2009to May 2012
- 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
- Elective CABG operation
- Age > 18 years
- Ejection fraction < 0.35
Who cannot join
- No consent
- Emergency operation
- Contra-indication to IABP placement
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Policlinico S.Donato
San Donato Milanese, Milan, 20097
IRCCS Policlinico San Donato
San Donato Milanese (Milan), 20097
About this study
Official title: Perioperative IABP in CABG Operations in Patients With Severely Depressed Left Ventricular Function: a Randomized, Controlled Trial
Since its first introduction in humans in 1962, Intra-Aortic Balloon Pump (IABP) is now the most commonly used therapeutic option to support failing heart in cardiac surgery. The main effects of IABP are an increase in diastolic blood pressure and therefore an improvement in coronary perfusion and a reduction of ventricular after load, thus increasing stroke volume and cardiac output. IABP-related complications include limb ischemia, bleeding at the site of IABP insertion, infection, and aortic dissection.
IABP could be used preoperatively, intraoperatively, or postoperatively. However, despite the wide use of the device, the optimal timing and use of IABP in high-risk patients undergoing cardiac surgery remains controversial. Time of insertion has been showed to affect hospital mortality, ranging from 18.8% to 19.6% for preoperative insertion, from 27.6% to 32.3% for intraoperative insertion, and from 39% to 40.5% for postoperative insertion. Several studies, randomized and non-randomized, have been conducted to address the impact of preoperative use of IABP on the outcome, each study including a relative small number of patients. In an effort to increase the strength of the results, two meta-analysis have been conducted and published in 2008. The objectives of both were to assess the effect on mortality and morbidity of using IABP preoperatively in high-risk patients undergoing coronary artery bypass grafting (CABG). Surprisingly, the meta-analysis from Field and co-workers was conducted on four randomized controlled trials (for a total of 193 patients included) published by the same author from the same institution, making the results not conclusive although favourable toward a beneficial effect of the preoperative use of IABP. Moreover, two of the randomized trials conducted by Christenson and co-workers and included in the above mentioned meta-analysis, were excluded from the meta-analysis from Dyub and co-workers because considered duplicates. Unfortunately, one study by Christenson and co-workers and included in the meta-analysis from Dyub was conducted on off-pump surgery, introducing another bias in the criteria of eligibility.
At present it is unclear whether the preoperative use of IABP in high-risk coronary patients scheduled for CABG operations leads to a better outcome. The experimental hypothesis of the present randomized, controlled trial (RCT) is that the placement of IABP immediately before beginning the surgical procedure induces a reduction of major morbidity after the operation.
Read the detailed description
RCT including patients scheduled for elective CABG surgery (with or without associated procedures) and having a left ventricular ejection fraction < 0.35. Exclusion criteria: age < 18 years, no patient's consent, contra-indications to the use of IABP (severe peripheral arteropathy; endovascular abdominal aortic prostheses).
Patients will be randomly allocated to either a control group or a treatment group. Patients in the control group will not receive an IABP preoperatively, and patients in the treatment arm will receive an IABP positioned immediately after the induction of anesthesia and before beginning surgery.
Randomization will be performed the day before the operation. Primary endpoint: reduction of major morbidity rate (defined as either prolonged (> 48 hours) mechanical ventilation, acute renal failure, mediastinitis, surgical revision, stroke).
Secondary endpoint: reduction in inotropic drug use, shortening of mechanical ventilation and ICU stay.
Interim analyses and stopping rules: interim analyses will be done at half (80 patients)and 2/3 (106 patients) of recruitment. The trial could be prematurely stopped in case of a difference in the primary endpoint reaching a P value of 0.005 at the first analysis, and 0.01 at the second.A specific stopping rule is settled for operative mortality (30 days) at 0.01 at the first interim analysis and 0.05 at the second interim analysis. Given the invasive nature and the costs of the intervention, a stopping rule for futility was settled in case of a lack of difference for the primary outcome. This was settled at a relative risk for the primary outcome not including the hypothesized value of 0.5 within 99% CI at the first interim analysis and 95% CI at the second.
- Being tested
- IABP
- Keywords
- CABG, coronary surgery, intra-aortic balloon pump, CABG operation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IABPProcedure or surgery
preoperative IABP placement
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No preoperative IABP; if needed, postoperative IABP placement |
| IABP | Active comparator | Preoperative IABP placement Receives: Procedure: IABP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major morbidity according to STS (30-days mortality, mechanical ventilation > 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure)
Measured: 30 days after operation
Secondary outcomes (2)
Time on mechanical ventilation; ICU and hospital stay
Measured: 30 days after the operation
IABP complications (lower limb ischemia, mesenteric ischemia, bleeding)
Measured: 30 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ranucci, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881192
- Sponsor's protocol ID
- IABPCABG
- Status last verified
- May 2012
- First submitted
- 14 Apr 2009
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dyub AM, Whitlock RP, Abouzahr LL, Cina CS. Preoperative intra-aortic balloon pump in patients undergoing coronary bypass surgery: a systematic review and meta-analysis. J Card Surg. 2008 Jan-Feb;23(1):79-86. doi: 10.1111/j.1540-8191.2007.00499.x.
PubMed 18290898Christenson JT, Licker M, Kalangos A. The role of intra-aortic counterpulsation in high-risk OPCAB surgery: a prospective randomized study. J Card Surg. 2003 Jul-Aug;18(4):286-94. doi: 10.1046/j.1540-8191.2003.02030.x.
PubMed 12869172Ranucci M, Castelvecchio S, Biondi A, de Vincentiis C, Ballotta A, Varrica A, Frigiola A, Menicanti L; Surgical and Clinical Outcome Research (SCORE) Group. A randomized controlled trial of preoperative intra-aortic balloon pump in coronary patients with poor left ventricular function undergoing coronary artery bypass surgery*. Crit Care Med. 2013 Nov;41(11):2476-83. doi: 10.1097/CCM.0b013e3182978dfc.
PubMed 23921278
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative IABP in CABG Operations in Patients With Severely Depressed Left Ventricular Function: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00881192
- Acronym / sponsor ID
- IABPCABG
- Keywords
- CABG, coronary surgery, intra-aortic balloon pump, CABG operation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Apr 2009 (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.
Since its first introduction in humans in 1962, Intra-Aortic Balloon Pump (IABP) is now the most commonly used therapeutic option to support failing heart in cardiac surgery. The main effects of IABP are an increase in diastolic blood pressure and therefore an improvement in coronary perfusion and a reduction of ventricular after load, thus increasing stroke volume and cardiac output. IABP-related complications include limb ischemia, bleeding at the site of IABP insertion, infection, and aortic dissection.
IABP could be used preoperatively, intraoperatively, or postoperatively. However, despite the wide use of the device, the optimal timing and use of IABP in high-risk patients undergoing cardiac surgery remains controversial. Time of insertion has been showed to affect hospital mortality, ranging from 18.8% to 19.6% for preoperative insertion, from 27.6% to 32.3% for intraoperative insertion, and from 39% to 40.5% for postoperative insertion. Several studies, randomized and non-randomized, have been conducted to address the impact of preoperative use of IABP on the outcome, each study including a relative small number of patients. In an effort to increase the strength of the results, two meta-analysis have been conducted and published in 2008. The objectives of both were to assess the effect on mortality and morbidity of using IABP preoperatively in high-risk patients undergoing coronary artery bypass grafting (CABG). Surprisingly, the meta-analysis from Field and co-workers was conducted on four randomized controlled trials (for a total of 193 patients included) published by the same author from the same institution, making the results not conclusive although favourable toward a beneficial effect of the preoperative use of IABP. Moreover, two of the randomized trials conducted by Christenson and co-workers and included in the above mentioned meta-analysis, were excluded from the meta-analysis from Dyub and co-workers because considered duplicates. Unfortunately, one study by Christenson and co-workers and included in the meta-analysis from Dyub was conducted on off-pump surgery, introducing another bias in the criteria of eligibility.
At present it is unclear whether the preoperative use of IABP in high-risk coronary patients scheduled for CABG operations leads to a better outcome. The experimental hypothesis of the present randomized, controlled trial (RCT) is that the placement of IABP immediately before beginning the surgical procedure induces a reduction of major morbidity after the operation.
Detailed description
RCT including patients scheduled for elective CABG surgery (with or without associated procedures) and having a left ventricular ejection fraction < 0.35. Exclusion criteria: age < 18 years, no patient's consent, contra-indications to the use of IABP (severe peripheral arteropathy; endovascular abdominal aortic prostheses).
Patients will be randomly allocated to either a control group or a treatment group. Patients in the control group will not receive an IABP preoperatively, and patients in the treatment arm will receive an IABP positioned immediately after the induction of anesthesia and before beginning surgery.
Randomization will be performed the day before the operation. Primary endpoint: reduction of major morbidity rate (defined as either prolonged (> 48 hours) mechanical ventilation, acute renal failure, mediastinitis, surgical revision, stroke).
Secondary endpoint: reduction in inotropic drug use, shortening of mechanical ventilation and ICU stay.
Interim analyses and stopping rules: interim analyses will be done at half (80 patients)and 2/3 (106 patients) of recruitment. The trial could be prematurely stopped in case of a difference in the primary endpoint reaching a P value of 0.005 at the first analysis, and 0.01 at the second.A specific stopping rule is settled for operative mortality (30 days) at 0.01 at the first interim analysis and 0.05 at the second interim analysis. Given the invasive nature and the costs of the intervention, a stopping rule for futility was settled in case of a lack of difference for the primary outcome. This was settled at a relative risk for the primary outcome not including the hypothesized value of 0.5 within 99% CI at the first interim analysis and 95% CI at the second.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No preoperative IABP; if needed, postoperative IABP placement |
| IABP | Active comparator | Procedure: IABPPreoperative IABP placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective CABG operation
- Age > 18 years
- Ejection fraction < 0.35
Key exclusion criteria (3 listed)
- No consent
- Emergency operation
- Contra-indication to IABP placement
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 |
|---|---|---|
| IABPpreoperative IABP placement | Procedure or surgery | IABP |
Primary outcome
Major morbidity according to STS (30-days mortality, mechanical ventilation > 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure)
Time frame: 30 days after operation
2 secondary outcomes
Time on mechanical ventilation; ICU and hospital stay
Time frame: 30 days after the operation
IABP complications (lower limb ischemia, mesenteric ischemia, bleeding)
Time frame: 30 days after the operation
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 10 May 2012.
- Background: PubMed 18290898Dyub AM, Whitlock RP, Abouzahr LL, Cina CS. Preoperative intra-aortic balloon pump in patients undergoing coronary bypass surgery: a systematic review and meta-analysis. J Card Surg. 2008 Jan-Feb;23(1):79-86. doi: 10.1111/j.1540-8191.2007.00499.x.
- Background: PubMed 12869172Christenson JT, Licker M, Kalangos A. The role of intra-aortic counterpulsation in high-risk OPCAB surgery: a prospective randomized study. J Card Surg. 2003 Jul-Aug;18(4):286-94. doi: 10.1046/j.1540-8191.2003.02030.x.
- Derived from this study: PubMed 23921278Ranucci M, Castelvecchio S, Biondi A, de Vincentiis C, Ballotta A, Varrica A, Frigiola A, Menicanti L; Surgical and Clinical Outcome Research (SCORE) Group. A randomized controlled trial of preoperative intra-aortic balloon pump in coronary patients with poor left ventricular function undergoing coronary artery bypass surgery*. Crit Care Med. 2013 Nov;41(11):2476-83. doi: 10.1097/CCM.0b013e3182978dfc.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IABP in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by IRCCS Policlinico S. Donato at 2 sites in Italy.
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 3 inclusion and 3 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 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Major morbidity according to STS (30-days mortality, mechanical ventilation > 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure) (time frame: 30 days after operation). 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 NCT00881192, which also lists 3 linked publications.
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 10 May 2012.