Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery

University of Sao Paulo126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

126

Conditions

Perioperative Hemodynamic Optimization Cardiac Surgery

Interventions

Goal-directed Resuscitation Therapy (GDT)OTHER

* 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%.

Standard protocolOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto do Coracao - InCor / HCFMUSP

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Composite of death or major postoperative complications

Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.