Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery (GRICS)

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

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 Overview

• Status: Completed
• Conditions: Cardiac Surgery; Perioperative Hemodynamic Optimization
• Intervention / Treatment: Other: Goal-directed Resuscitation Therapy (GDT); Other: Standard protocol

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403000
    • Instituto do Coracao - InCor / HCFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Ludhmila A Hajjar, MD, PhD, University of Sao Paulo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: October 17, 2011
• First Submitted That Met QC Criteria: November 10, 2011
• First Posted (Estimate): November 11, 2011

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Cardiac surgery; Goal-directed therapy; Hemodynamic optimization
• Other Study ID Numbers: 0565/11