Perioperative Hemodynamic Optimization, Cardiac Surgery
Conditions
Keywords
Goal-directed therapy, Hemodynamic optimization, Cardiac surgery
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.
Interventions
* A target value of a cardiac index (CI) greater than 3.0 L/min/m2 will be sought. * The first step will be fluid resuscitation with 250ml aliquots of Lactated Ringer's solution whenever the CI is lower than 3,0 L/min/m2 and systolic volume index (SVI) is lower than 35ml/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period. * When the CI is lower than or equal to 3,0L/min/m2 and SVI higher than or equal to 35 ml/m2, dobutamine will be initiated with increasing doses up to 20mcg/kg/min. * The final step will be red blood transfusion to reach a hematocrit higher than 28%.
OTHERStandard protocol
The control group will be managed by the anesthetic team in the operative room and by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of death or major postoperative complications | within 30 days after cardiac surgery | Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of ICU stay and hospital stay. | within 30 days after cardiac surgery | To compare the number of days of ICU stay and hospital stay between groups. |
| Tissue hypoperfusion markers | within 30 days after cardiac surgery | To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups. |
| Cardiovascular measures | within 30 days after cardiac surgery | To compare levels of BNP, myocardial enzymes, echocardiographic measures and free-days of vasopressors and inotropes between groups. |
| Mechanical ventilation | within 30 days after cardiac surgery | To compare the number of mechanical ventilation free-days between groups. |
| Fluid balance | during ICU stay | To compare fluid balance during ICU stay between groups. |
Countries
Brazil
Outcome results
None listed