Goal-Directed Therapy in Cancer Surgery (GRICS II)

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Care
• Intervention / Treatment: Other: Standard protocol; Other: Goal-directed Resuscitation Therapy (GDT)

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 01246000
      • Recruiting
      • Intensive Care Unit of the Cancer Institute of Sao Paulo State
      • Contact: Aline Müller, MD; Phone Number: 55-11-974130225; Email: dra.alinemuller@gmail.com
      • Principal Investigator: Aline Müller, MD
      • Principal Investigator: Ludhmila Hajjar, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard group	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.
Active Comparator: Goal-directed therapy (GDT) protocol	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	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.	30 days after randomization
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
Daily SOFA score	Daily sequential organ failure assessment score within the first 7 days after randomization	7 days after randomization
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
Respiratory complications	Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria	30 days after randomization
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
Neurological complications	To compare the incidence of stroke between groups within 30 days after randomization.	30 days after randomization
Severe infectious complications	To compare the incidence, between groups, of infectious complications defined as a new septic shock.	30 days after randomization
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• Gerent ARM, Almeida JP, Fominskiy E, Landoni G, de Oliveira GQ, Rizk SI, Fukushima JT, Simoes CM, Ribeiro U Jr, Park CL, Nakamura RE, Franco RA, Candido PI, Tavares CR, Camara L, Dos Santos Rocha Ferreira G, de Almeida EPM, Filho RK, Galas FRBG, Hajjar LA. Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis. Crit Care. 2018 May 23;22(1):133. doi: 10.1186/s13054-018-2055-4.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: September 16, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 19, 2013

Study Record Updates

• Last Update Posted (Estimate): September 19, 2013
• Last Update Submitted That Met QC Criteria: September 18, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: GRICS-02