Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

NCT01221116 | Terminated

• 1 other identifier: INSI-study
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit

Conditions

Heart Failure; Cardiac Surgery

Keywords

coronary artery disease,; aortic stenosis,; heart failure

Outcome Measures

Primary Outcomes (1)

• Need for inotropic agents or IABP (intra aortal balloon pump)

  jan 2003 - dec 2008

Secondary Outcomes (1)

• Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data.

  jan 2003-dec 2008

Study Arms (1)

1: Type of surgery

NO INTERVENTION

Two types of patients are compared (placebo vs levosimendan): CABG - coronary artery bypass grafting and AVR - aortic valve replacement (either with or without CABG - coronary artery bypass grafting)

Drug: levosimendan

Interventions

levosimendan DRUG

levosimendan 0.1 microgram/kg/min) for 24 hours

Also known as: Type of surgery

1: Type of surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• EF (ejection fraction)\<40%

You may not qualify if:

• renal failure, liver failure

Sponsors & Collaborators

• Ullevaal University Hospital: lead

Study Sites (1)

Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital

Oslo, Oslo County, 0407, Norway

Location

MeSH Terms

Conditions

Heart Failure; Coronary Artery Disease; Aortic Valve Stenosis

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Knut A Kirkebøen, MD, PhD

  Ullevaal University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 14, 2010
• Study Start: January 1, 2003
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 2, 2010

Record last verified: 2003-01

Locations

NO (1)