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

Cardiac Surgery Clinical Trial

— GRICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470976
• Other study ID #: 0565/11
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2011
• Last updated: February 3, 2016
• Start date: November 2011
• Est. completion date: July 2014

Study information

• Verified date: February 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiac Surgery
• Perioperative Hemodynamic Optimization

Intervention

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%.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto do Coracao - InCor / HCFMUSP	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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, Leão 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	Mechanical ventilation	To compare the number of mechanical ventilation free-days between groups.	within 30 days after cardiac surgery	No
Secondary	Fluid balance	To compare fluid balance during ICU stay between groups.	during ICU stay	No