Clinical trial NCT01470976: Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery
Official title: Randomized Controlled Trial of Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perioperative Hemodynamic Optimization
Cardiac Surgery
Keywords: Goal-directed therapy
Hemodynamic optimization
Cardiac surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-11-11
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 after cardiac surgery. The hypothesis is that there are better outcomes when achieving a cardiac index higher than 3L/min/m2 in those patients with an arterial lactate higher than 1.5 mmol/L.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Composite of death or major postoperative complications
timeFrame: within 30 days after cardiac surgery
Secondary outcomes:
measure: Duration of ICU stay and hospital stay.
timeFrame: within 30 days after cardiac surgery
measure: Tissue hypoperfusion markers
timeFrame: within 30 days after cardiac surgery
measure: Cardiovascular measures
timeFrame: within 30 days after cardiac surgery
measure: Mechanical ventilation
timeFrame: within 30 days after cardiac surgery
measure: Fluid balance
timeFrame: during ICU stay
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coracao - InCor / HCFMUSP
Study officials:
affiliation: University of Sao Paulo
name: Ludhmila A Hajjar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hajjar LA, Fukushima JT, Osawa E, Almeida JP, Galas FR. Dobutamine administration in patients after cardiac surgery: beneficial or harmful? Crit Care. 2011;15(5):444. doi: 10.1186/cc10439. Epub 2011 Sep 27. No abstract available.
citation: Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.