Overview

This trial is active, not recruiting.

Conditions myocardial infarction, shock, cardiogenic
Treatment intraaortic balloon pump
Phase phase 4
Sponsor University of Leipzig
Start date June 2009
End date June 2012
Trial size 600 participants
Trial identifier NCT00491036, 342

Summary

Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration.

The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab
intraaortic balloon pump
intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used
(No Intervention)
Patients in cardiogenic shock in this group get no intraaortic balloon pump

Primary Outcomes

Measure
30-day mortality
time frame: 30 day

Secondary Outcomes

Measure
Inflammatory markers (CRP and white blood cell count)
time frame: 4 days
Hemodynamic Parameters (Blood pressure, Heart rate)
time frame: 3 days
Time till hemodynamic stabilization
time frame: 30 days
Catecholamine dose and duration of catecholamines
time frame: 30 days
Mean and area under the curve of serum lactate
time frame: 48 hours
Creatinine clearance until stabilization
time frame: 4 days
requirement for hemofiltration or dialysis
time frame: 4 days
length of ICU stay
time frame: 30 days
length of mechanical ventilation
time frame: 30 days
SAPS-II Score
time frame: 4 days
requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months
time frame: 60 months
long-term mortality at 6, 12 and approximately 60 months
time frame: 60 months
quality of life at 30 days and approximately 60 months
time frame: 60 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with - intended revascularization (PCI or CABG) - Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole - Signs of pulmonary congestion - Signs of impaired organ perfusion with at least one of the following: - Altered mental status - Cold, clammy skin - Urine output <30 ml/h - Serum lactate >2mmol/l - Informed consent Exclusion criteria: - Resuscitation > 30 minutes - Cerebral deficit with fixed dilated pupils - No intrinsic heart action - Mechanical infarction complication - Onset of shock > 12 h - Severe peripheral artery disease - Aortic regurgitation > II.° - Age > 90 years - shock of other cause - Other severe concomitant disease - participation in another trial

Additional Information

Official title Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Leipzig.