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Completed

NCT Number: NCT00491036

Intraaortic Balloon Pump in Cardiogenic Shock II

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zentralklinik Bad Berka GmbH, Bad Berka, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraaortic balloon pump

Device

intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used

Primary outcomes

  1. 30-day mortality

    Time frame: 30 day

Secondary outcomes

  1. Inflammatory markers (CRP and white blood cell count)

    Time frame: 4 days

  2. Hemodynamic Parameters (Blood pressure, Heart rate)

    Time frame: 3 days

  3. Time till hemodynamic stabilization

    Time frame: 30 days

  4. Catecholamine dose and duration of catecholamines

    Time frame: 30 days

  5. Mean and area under the curve of serum lactate

    Time frame: 48 hours

  6. Creatinine clearance until stabilization

    Time frame: 4 days

  7. requirement for hemofiltration or dialysis

    Time frame: 4 days

  8. length of ICU stay

    Time frame: 30 days

  9. length of mechanical ventilation

    Time frame: 30 days

  10. SAPS-II Score

    Time frame: 4 days

  11. requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months

    Time frame: 60 months

  12. long-term mortality at 6, 12 and approximately 60 months

    Time frame: 60 months

  13. quality of life at 30 days and approximately 60 months

    Time frame: 60 months

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Acronym: IABP-SHOCK II

Important dates

Study start
2009
Primary completion
2012
Study completion
2016
First posted
Jun 25, 2007
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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