Overview

Levosimendan in High Risk Patients Undergoing Cardiac Surgery

Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
All
Summary
Low cardiac output syndrome (LCOs) is a serious complication in critically ill patients or those undergoing major surgery, resulting in multiple organ damage with significant in-hospital and long-term morbidity and mortality, as well as prolonged hospital stay. In this setting the mortality rate is distressingly high despite improvements in intensive care treatment, but survivors have an acceptable quality of life.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Università Vita-Salute San Raffaele
Treatments:
Simendan
Criteria
Inclusion Criteria:

- Written informed consent

- Age > 18 years

- Perioperative myocardial dysfunction

Exclusion Criteria:

- Previous unusual response to levosimendan or soluvit or any of their components

- Inclusion in other randomised controlled studies in the previous 30 days

- Levosimendan administration in the previous 30 days

- Parkinson's disease

- Emergency operation

- Kidney or liver transplant

- Liver cirrhosis (Child B or C)

- Decision to use ECMO (ECMO already started or planned)

- Do not resuscitate patient