Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery (GRICS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01470976|
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : February 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Perioperative Hemodynamic Optimization Cardiac Surgery||Other: Goal-directed Resuscitation Therapy (GDT) Other: Standard protocol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Controlled Trial of Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||July 2014|
|Active Comparator: Goal-directed Therapy (GDT) Protocol||
Other: Goal-directed Resuscitation Therapy (GDT)
Other Name: 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.
- Composite of death or major postoperative complications [ Time Frame: 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.
- Duration of ICU stay and hospital stay. [ Time Frame: within 30 days after cardiac surgery ]To compare the number of days of ICU stay and hospital stay between groups.
- Tissue hypoperfusion markers [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: within 30 days after cardiac surgery ]To compare the number of mechanical ventilation free-days between groups.
- Fluid balance [ Time Frame: during ICU stay ]To compare fluid balance during ICU stay between groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470976
|Instituto do Coracao - InCor / HCFMUSP|
|Sao Paulo, Brazil, 05403000|
|Principal Investigator:||Ludhmila A Hajjar, MD, PhD||University of Sao Paulo|