Intraaortic Balloon Pump in Cardiogenic Shock II

Myocardial Infarction Clinical Trial

— IABP-SHOCK II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491036
• Other study ID #: 342
• Status: Completed
• Phase: Phase 4
• First received: June 22, 2007
• Last updated: May 1, 2017
• Start date: June 2009
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2016
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Shock
• Shock, Cardiogenic

Intervention

Device:
• Intraaortic balloon pump
intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Segeberger Kliniken Gmbh	Bad Segeberg
Germany	Charité Berlin, Campus Benjamin Franklin	Berlin
Germany	Heart Center Bernau - Brandenburg	Bernau
Germany	Herzzentrum Cottbus	Cottbus
Germany	Klinikum Lippe-Detmold	Detmold
Germany	Krankenhaus Fulda	Fulda
Germany	University Greifswald	Greifswald
Germany	Martin-Luther-Universität Halle-Wittenberg	Halle
Germany	SLK-Kliniken Heilbronn	Heilbronn
Germany	Oberhavel-Kliniken Hennigsdorf	Hennigsdorf
Germany	Klinikum der Universität Jena	Jena
Germany	Asklepios Klinik Langen	Langen
Germany	University of Leipzig - Heart Center	Leipzig
Germany	University of Lübeck	Lübeck
Germany	Klinikum der Stadt Ludwigshafen am Rhein	Ludwigshafen
Germany	Otto-von-Guericke University Magdeburg	Magdeburg
Germany	German Heart Center Munich	Munich
Germany	Krankenhaus der Barmherzigen Brüder	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

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