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

NCT00881192 | Completed

• 1 other identifier: IABPCABG
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Coronary Artery Disease; Coronary Artery Bypass Grafting

Keywords

CABG; coronary surgery; intra-aortic balloon pump; CABG operation

Outcome Measures

Primary Outcomes (1)

• Major morbidity according to STS (30-days mortality, mechanical ventilation > 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure)

  30 days after operation

Secondary Outcomes (2)

• Time on mechanical ventilation; ICU and hospital stay

  30 days after the operation

• IABP complications (lower limb ischemia, mesenteric ischemia, bleeding)

  30 days after the operation

Study Arms (2)

Control

NO INTERVENTION

No preoperative IABP; if needed, postoperative IABP placement

IABP

ACTIVE COMPARATOR

Preoperative IABP placement

Procedure: IABP

Interventions

IABP PROCEDURE

preoperative IABP placement

IABP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No consent
• Emergency operation
• Contra-indication to IABP placement

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (2)

IRCCS Policlinico S.Donato

San Donato Milanese, Milan, 20097, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese (Milan), 20097, Italy

Location

Related Publications (3)

• 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.

  PMID: 18290898 BACKGROUND

• Christenson 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.

  PMID: 12869172 BACKGROUND

• Ranucci 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.

  PMID: 23921278 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia and Reanimation Clinical Research Director

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

IT (2)