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

PHASE3CompletedINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

February 28, 2014

Study Completion Date

July 31, 2014

Conditions
Perioperative Hemodynamic OptimizationCardiac Surgery
Interventions
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

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.

Trial Locations (1)

05403000

Instituto do Coracao - InCor / HCFMUSP, São Paulo

All Listed Sponsors
collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

lead

University of Sao Paulo

OTHER

NCT01470976 - Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery | Biotech Hunter | Biotech Hunter