Goal-Directed Therapy in Cancer Surgery (GRICS II)

This study is currently recruiting participants.
Verified September 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Ludhmila Abrahão Hajjar, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01946269
First received: September 16, 2013
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Postoperative Care
Other: Goal-directed Resuscitation Therapy (GDT)
Other: Standard protocol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Composite endpoint of death or major postoperative complications [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
    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:
  • Duration of ICU stay and hospital stay [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
    To compare the number of days of ICU stay and hospital stay between groups.

  • Tissue hypoperfusion markers [ Time Frame: 7 days after randomization ] [ Designated as safety issue: Yes ]
    To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.

  • Daily SOFA score [ Time Frame: 7 days after randomization ] [ Designated as safety issue: Yes ]
    Daily sequential organ failure assessment score within the first 7 days after randomization

  • Cardiovascular complications [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
    Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria

  • Severe Renal complication [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
    Severe renal complication will be defined as renal failure according to Acute Kidney Injury Network (AKIN) stage 3.

  • Neurological complications [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
    To compare the incidence of stroke between groups within 30 days after randomization.

  • Severe infectious complications [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
    To compare the incidence, between groups, of infectious complications defined as a new septic shock.

  • Surgical complications [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
    To compare the incidence between groups of surgical complication. Surgical complication will be defined as reoperation due to any reason, hospital readmission or death


Estimated Enrollment: 128
Study Start Date: September 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946269

Contacts
Contact: Aline Müller, MD 55-11-974130225 dra.alinemuller@gmail.com

Locations
Brazil
Intensive Care Unit of the Cancer Institute of Sao Paulo State Recruiting
Sao Paulo, SP, Brazil, 01246000
Contact: Aline Müller, MD    55-11-974130225    dra.alinemuller@gmail.com   
Principal Investigator: Aline Müller, MD         
Principal Investigator: Ludhmila Hajjar, MD, PhD         
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

Responsible Party: Ludhmila Abrahão Hajjar, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01946269     History of Changes
Other Study ID Numbers: GRICS-02
Study First Received: September 16, 2013
Last Updated: September 18, 2013
Health Authority: Brazil: Ministry of Health

ClinicalTrials.gov processed this record on April 17, 2014