Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II)

May 1, 2017 updated by: Holger Thiele, University of Leipzig

Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Bad Krozingen, Germany, 79189
        • Herzzentrum Bad Krozingen
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken GmbH
      • Berlin, Germany, 12200
        • Charité Berlin, Campus Benjamin Franklin
      • Bernau, Germany, 16321
        • Heart Center Bernau - Brandenburg
      • Cottbus, Germany, 03048
        • Herzzentrum Cottbus
      • Detmold, Germany, 32756
        • Klinikum Lippe-Detmold
      • Fulda, Germany, 36043
        • Krankenhaus Fulda
      • Greifswald, Germany, 17475
        • University Greifswald
      • Halle, Germany, 06097
        • Martin-Luther-Universität Halle-Wittenberg
      • Heilbronn, Germany, 74078
        • SLK-Kliniken Heilbronn
      • Hennigsdorf, Germany, 16761
        • Oberhavel-Kliniken Hennigsdorf
      • Jena, Germany, 07747
        • Klinikum der Universität Jena
      • Langen, Germany, 63225
        • Asklepios Klinik Langen
      • Leipzig, Germany, 04289
        • University of Leipzig - Heart Center
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein
      • Lübeck, Germany, 23538
        • University of Lubeck
      • Magdeburg, Germany, 39120
        • Otto-von-Guericke University Magdeburg
      • Munich, Germany, 80636
        • German Heart Center Munich
      • Regensburg, Germany, 93049
        • Krankenhaus der Barmherzigen Brüder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intraaortic balloon pump
Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab
Device: Intraaortic balloon pump
intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used
No Intervention: No intraaortic balloon pump
Patients in cardiogenic shock in this group get no intraaortic balloon pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30-day mortality
Time Frame: 30 day
30 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Study Chair: Holger Thiele, MD, Heart Center Leipzig - University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 22, 2007

First Submitted That Met QC Criteria

June 22, 2007

First Posted (Estimate)

June 25, 2007

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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