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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01950130
Other study ID # A-1124
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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)
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