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Levosimendan and Myocardial Protection

NCT00610350 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-02-07

No results posted yet for this study

Summary

The aim of this study is to investigate whether pharmacological pre-treatment with levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective myocardial revascularization under cardiopulmonary bypass.

Conditions

  • Myocardial Protection

Interventions

DRUG

levosimendan

24 μg/kg administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB

DRUG

Placebo

an identical-appearing placebo prepared and labelled by the pharmacy was administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB

Sponsors & Collaborators

  • University College London Hospitals

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Vincenzo De Santis, M.D. · University of Roma La Sapienza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00610350 on ClinicalTrials.gov