Perioperative Intra-Aortic Balloon Pump (IABP) in Coronary Artery Bypass Grafting (CABG) Operations in Patients With Severely Depressed Left Ventricular Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marco Ranucci, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier:
NCT00881192
First received: April 14, 2009
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Coronary Artery Bypass Grafting
Procedure: IABP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Perioperative IABP in CABG Operations in Patients With Severely Depressed Left Ventricular Function: a Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by IRCCS Policlinico S. Donato:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time on mechanical ventilation; ICU and hospital stay [ Time Frame: 30 days after the operation ] [ Designated as safety issue: No ]
  • IABP complications (lower limb ischemia, mesenteric ischemia, bleeding) [ Time Frame: 30 days after the operation ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: April 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No preoperative IABP; if needed, postoperative IABP placement
Active Comparator: IABP
Preoperative IABP placement
Procedure: IABP
preoperative IABP placement

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective CABG operation
  • Age > 18 years
  • Ejection fraction < 0.35

Exclusion Criteria:

  • No consent
  • Emergency operation
  • Contra-indication to IABP placement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881192

Locations
Italy
IRCCS Policlinico S.Donato
San Donato Milanese, Milan, Italy, 20097
IRCCS Policlinico San Donato
San Donato Milanese (Milan), Italy, 20097
Sponsors and Collaborators
IRCCS Policlinico S. Donato
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Ranucci, Anesthesia and Reanimation Clinical Research Director, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT00881192     History of Changes
Other Study ID Numbers: IABPCABG
Study First Received: April 14, 2009
Last Updated: May 9, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by IRCCS Policlinico S. Donato:
CABG
coronary surgery
intra-aortic balloon pump
CABG operation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014