Goal-Directed Therapy in Cancer Surgery

Postoperative Care Clinical Trial

— GRICS II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01946269
• Other study ID #: GRICS-02
• Status: Recruiting
• Phase: Phase 3
• First received: September 16, 2013
• Last updated: September 18, 2013
• Start date: September 2013
• Est. completion date: May 2014

Study information

• Verified date: September 2013
• Source: University of Sao Paulo
• Contact: Aline Müller, MD
• Phone: 55-11-974130225
• Email: dra.alinemuller[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients admitted to ICU in immediate postoperatory of major abdominal surgery for cancer treatment

• Age over 18 years-old

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Care

Intervention

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.
• Standard protocol
The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.

Locations

Country	Name	City	State
Brazil	Intensive Care Unit of the Cancer Institute of Sao Paulo State	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint 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.	30 days after randomization	Yes
Secondary	Duration of ICU stay and hospital stay	To compare the number of days of ICU stay and hospital stay between groups.	30 days after randomization	Yes
Secondary	Tissue hypoperfusion markers	To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.	7 days after randomization	Yes
Secondary	Daily SOFA score	Daily sequential organ failure assessment score within the first 7 days after randomization	7 days after randomization	Yes
Secondary	Cardiovascular complications	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.	30 days after randomization	Yes
Secondary	Respiratory complications	Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria	30 days after randomization	Yes
Secondary	Severe Renal complication	Severe renal complication will be defined as renal failure according to Acute Kidney Injury Network (AKIN) stage 3.	30 days after randomization	Yes
Secondary	Neurological complications	To compare the incidence of stroke between groups within 30 days after randomization.	30 days after randomization	Yes
Secondary	Severe infectious complications	To compare the incidence, between groups, of infectious complications defined as a new septic shock.	30 days after randomization	Yes
Secondary	Surgical complications	To compare the incidence between groups of surgical complication. Surgical complication will be defined as reoperation due to any reason, hospital readmission or death	30 days after randomization	Yes