Prophylactic IABP in High-risk Patients Undergoing CABG

Coronary Artery Disease Clinical Trial

Official title:

Prophylactic Preoperative Inatraaortic Balloon Pump (IABP) in High-risk Patients Undergoing Coronary Artery Bypass Surgery (CABG)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01950130
• Other study ID #: A-1124
• Status: Withdrawn
• Phase: N/A
• Start date: June 2015
• Est. completion date: February 2018

Study information

• Verified date: November 2021
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Due to advances and increased practice of interventional therapy for coronary artery disease, the rate of high-risk patients with severe coronary disease and reduced left ventricular function among patients undergoing coronary artery bypass grafting surgery (CABG) is increasing. The perioperative mortality in these patients is ≥ 5%. The perioperative and operative management for these patients has to be optimized in order to reduce their perioperative morbidity and mortality. One of the central aspects is perioperative maintenance of hemodynamic stability. The use of prophylactic IABP is a partly established, but not sufficiently evidence-based measure to reduce ventricular afterload and improve coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive procedure with potential complications. The planned trial should give an explicit answer, whether preoperative prophylactic IABP decreases 30-day all-cause mortality (primary endpoint) and long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative conservative treatment in high-risk patients undergoing CABG.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key inclusion criteria:

Hemodynamically stable high-risk patients before CABG, defined by the following criteria:

• Age >18 years

• Isolated CABG planned

• Informed consent in trial participation given

• Any left ventricular functional impairment (regional wall motion abnormality or global LVEF<55%) assessed via ventriculography or transthoracic or transeophageal echocardiography

• Elevated cardiac biomarkers (CK-MB > 6% of total-CK, Troponin I > 3-fold of specific test reference) or myocardial infarction (NSTEMI or STEMI) within the last 4 days.

Key exclusion criteria:

• Contraindications for IABP

• Cardiogenic shock

• Shock of any other cause

• Critical preoperative state according to EuroSCORE II-criteria

• Cardiac surgical procedure other than CABG planned

• Severe comorbidity with life expectancy < 6 months

• Incapability of giving informed consent

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Procedure:
• Preoperative IABC
IABP-Insertion upon inclusion into the trial and admission to the ICU

Locations

Country	Name	City	State
Germany	Department of Adult and Pediatric Cardiovascular Surgery	Giessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day all-cause mortality post CABG [%]		30 days
Secondary	Survival at 3, 6, 12 months [%]		3, 6 and 12 months
Secondary	Duration of ICU stay [h]		48 hours (average)
Secondary	Dependence on medical inotropic support		48 hours (average)
Secondary	IABP-associated complications	IABP-associated complications occur most often during IABP-support. However, after weaning from IABP, patients can still have bleeding complications or thrombembolic complications. Therefore, IABP-associated complications are monitored during the whole hospital stay	8 days (average)