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

Study Overview
=================
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.

Official Title
-----------------
Randomized Controlled Trial of Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery

Conditions
-----------------
Perioperative Hemodynamic Optimization, Cardiac Surgery

Intervention / Treatment
-----------------
* Other: Goal-directed Resuscitation Therapy (GDT)
* Other: Standard protocol


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Goal-directed Therapy (GDT) Protocol<br> | Other: Goal-directed Resuscitation Therapy (GDT)<br>* 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%.<br>* Other names: LiDCO Rapid will be used to calculate CI and SVI.;|
| Active Comparator: Standard Protocol<br> | Other: Standard protocol<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 30 days after cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ICU stay and hospital stay. | To compare the number of days of ICU stay and hospital stay between groups. | within 30 days after cardiac surgery | 
| Tissue hypoperfusion markers | To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups. | within 30 days after cardiac surgery | 
| Cardiovascular measures | To compare levels of BNP, myocardial enzymes, echocardiographic measures and free-days of vasopressors and inotropes between groups. | within 30 days after cardiac surgery | 
| Mechanical ventilation | To compare the number of mechanical ventilation free-days between groups. | within 30 days after cardiac surgery | 
| Fluid balance | To compare fluid balance during ICU stay between groups. | during ICU stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Goal-directed therapy, Hemodynamic optimization, Cardiac surgery