Goal-directed Resuscitation in High-risk Patients Undergo... | NCT01470976 | Trialant

Goal-directed Resuscitation in High-risk Patients Undergo... | NCT01470976 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Goal-directed Therapy (GDT) Protocol	Active Comparator		Other: Goal-directed Resuscitation Therapy (GDT)
Standard Protocol	Active Comparator		Other: Standard protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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%.

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21958463	Background	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.
20940381	Background	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.