Goal-Directed Therapy in Cancer Surgery (GRICS II)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014