NCT01946269

Goal-Directed Therapy in Cancer Surgery

Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a goal-directed resuscitation therapy within the first 8 hours after major abdominal cancer surgery reduces postoperative complications compared to a standard therapy.

Conditions

• Postoperative Care

Interventions

Type	Name	Description
OTHER	Goal-directed Resuscitation Therapy (GDT)	* A target value of a cardiac index (CI) greater than 2.5 L/min/m2 and a mean arterial pressure of 70 mmHg will be sought. * The first step will be fluid resuscitation with 200ml aliquots of Lactated Ringer's solution plus human albumin 20% 50 mL whenever the CI is lower than 2.5 L/min/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period or CI increases less than 10%. * When the CI is lower than or equal to 2.5L/min/m2 despite of fluid challenge, 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%. * If necessary, norepinephrine infusion will be used to maintain a mean arterial pressure above 70 mmHg.
OTHER	Standard protocol	The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-03-01
• Completion: 2014-05-01
• First posted: 2013-09-19
• Last updated: 2013-09-19

Locations

1 site across 1 country: Brazil