Goal-Directed Therapy in Cancer Surgery

Phase 3

• Conditions: Postoperative Care
• Interventions: Other: Standard protocol; Other: Goal-directed Resuscitation Therapy (GDT)

• Registration Number: NCT01946269
• Lead Sponsor: University of Sao Paulo

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2013-09
• Study Start: 2013-09
• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-18
• Last Update Submitted: 2013-09-18
• Study First Posted: 2013-09-19
• Last Update Posted: 2013-09-19
• Primary Completion: 2014-03
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Patients admitted to ICU in immediate postoperatory of major abdominal surgery for cancer treatment
• Age over 18 years-old

Read More

Exclusion Criteria

• Weight under 55 kilograms or over 140 kilograms;
• Contra-indication for invasive hemodynamic monitoring;
• Expected ICU permanence less than 24 hours;
• Active bleeding
• Vasoplegic shock with noradrenaline dose higher than 1mcg/kg/min
• Enrolled in other study
• Refuse to consent

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard group	Standard protocol	-
Goal-directed therapy (GDT) protocol	Goal-directed Resuscitation Therapy (GDT)	-

Primary Outcome Measures

Name	Time	Method
Composite endpoint of death or major postoperative complications	30 days after randomization	Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.

Secondary Outcome Measures

Name	Time	Method
Duration of ICU stay and hospital stay	30 days after randomization	To compare the number of days of ICU stay and hospital stay between groups.
Tissue hypoperfusion markers	7 days after randomization	To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.
Daily SOFA score	7 days after randomization	Daily sequential organ failure assessment score within the first 7 days after randomization
Cardiovascular complications	30 days after randomization	To compare the incidence of cardiovascular complications between groups. Cardiovascular complications will be defined as myocardial ischemia, acute decompensated heart failure, mesenteric ischemia, pulmonary thromboembolism and peripheral vascular ischemia.
Respiratory complications	30 days after randomization	Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria
Severe Renal complication	30 days after randomization	Severe renal complication will be defined as renal failure according to Acute Kidney Injury Network (AKIN) stage 3.
Neurological complications	30 days after randomization	To compare the incidence of stroke between groups within 30 days after randomization.
Severe infectious complications	30 days after randomization	To compare the incidence, between groups, of infectious complications defined as a new septic shock.
Surgical complications	30 days after randomization	To compare the incidence between groups of surgical complication. Surgical complication will be defined as reoperation due to any reason, hospital readmission or death

Trial Locations

Locations (1)

Intensive Care Unit of the Cancer Institute of Sao Paulo State; 🇧🇷 Sao Paulo, SP, Brazil