Status:
COMPLETED
Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Perioperative Hemodynamic Optimization
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary aim of the study is to investigate whether a goal-directed resuscitation therapy in high-risk patients through cardiac index optimization using the LiDCO Rapid device reduces complications...
Eligibility Criteria
Inclusion
- All elective primary and redo adult cardiac surgical patients for coronary artery bypass grafting, valve procedure or combined procedures
- Adults patients
- Written informed consent
- One of the following criteria:
- EuroSCORE (European System for Cardiac Operative Risk Evaluation) higher than or equal to 6
- Ejection fraction lower than 50%
- Recent myocardial infarction
- Unstable angina
Exclusion
- Age less than 18 years
- Infectious endocarditis
- Transplant procedures
- Emergency procedures
- Pulmonary hypertension
- Preoperative cardiogenic shock or use of dobutamine
- Congenital procedures
- Need for intra-aortic balloon pump (IABP)
- Noradrenaline dose higher than 1mcg/kg/min
- Pregnancy
- Patients who refused participation in the study
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01470976
Start Date
November 1 2011
End Date
July 1 2014
Last Update
February 4 2016
Active Locations (1)
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1
Instituto do Coracao - InCor / HCFMUSP
São Paulo, São Paulo, Brazil, 05403000