Levosimendan Versus Dobutamine in Cardiopatic Patients Undergoing Major Non Cardiac Surgery

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02012946
• Other study ID #: levodobu
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 11, 2013
• Last updated: December 11, 2013
• Start date: December 2013

Study information

• Verified date: December 2013
• Source: Azienda Policlinico Umberto I
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Agenzia Italiana del Farmaco AIFA
• Study type: Interventional

Clinical Trial Summary

This study wants to investigate the hemodynamic changes in cardiopatic patients undergoing major non cardiac surgery, during and after the continuous infusion of levosimendan or dobutamine.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• EF < 40%, no liver and renal disfynction, chronic cardiopathy

Exclusion Criteria:

• acute coronary syndrome, life expectation <30 days, hemodialysis, ventricular tachycardia/ventricular fibrillation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Levosimendan
patient receiving levosimendan
• Dobutamine
patient receiving dobutamine

Locations

Country	Name	City	State
Italy	Francesco Pugliese	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac index		1-3 days	No