Intraaortic Balloon Pump in Cardiogenic Shock II

Phase 4

Completed

• Conditions: Myocardial Infarction; Shock, Cardiogenic
• Interventions: Device: Intraaortic balloon pump

• Registration Number: NCT00491036
• Lead Sponsor: University of Leipzig

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-22
• Study First Submitted QC: 2007-06-22
• Study First Posted: 2007-06-25
• Study Start: 2009-06
• Primary Completion: 2012-06
• Study Completion: 2016-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraaortic balloon pump	Intraaortic balloon pump	Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab

Primary Outcome Measures

Name	Time	Method
30-day mortality	30 day

Secondary Outcome Measures

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

Trial Locations

Locations (20)

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Oberhavel-Kliniken Hennigsdorf; 🇩🇪 Hennigsdorf, Germany

Asklepios Klinik Langen; 🇩🇪 Langen, Germany

Klinikum Lippe-Detmold; 🇩🇪 Detmold, Germany

Krankenhaus Fulda; 🇩🇪 Fulda, Germany

Charité Berlin, Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Segeberger Kliniken Gmbh; 🇩🇪 Bad Segeberg, Germany

Klinikum der Stadt Ludwigshafen am Rhein; 🇩🇪 Ludwigshafen, Germany

Heart Center Bernau - Brandenburg; 🇩🇪 Bernau, Germany

SLK-Kliniken Heilbronn; 🇩🇪 Heilbronn, Germany

Klinikum der Universität Jena; 🇩🇪 Jena, Germany

University of Lübeck; 🇩🇪 Lübeck, Germany

Otto-von-Guericke University Magdeburg; 🇩🇪 Magdeburg, Germany

University Greifswald; 🇩🇪 Greifswald, Germany

Martin-Luther-Universität Halle-Wittenberg; 🇩🇪 Halle, Germany

German Heart Center Munich; 🇩🇪 Munich, Germany

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Herzzentrum Cottbus; 🇩🇪 Cottbus, Germany

University of Leipzig - Heart Center; 🇩🇪 Leipzig, Germany

Krankenhaus der Barmherzigen Brüder; 🇩🇪 Regensburg, Germany