GRICS II: Goal-Directed Therapy in Cancer Surgery

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01946269
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 16.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Care	Other: Goal-directed Resuscitation Therapy (GDT); Other: Standard protocol	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study
• Study Start Date: Sep 1, 2013
• Anticipated Primary Completion Date: Mar 1, 2014
• Anticipated Study Completion Date: May 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. Daily SOFA score [7 days after randomization]

   Daily sequential organ failure assessment score within the first 7 days after randomization

4. 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.

5. Respiratory complications [30 days after randomization]

   Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria

6. 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.

7. Neurological complications [30 days after randomization]

   To compare the incidence of stroke between groups within 30 days after randomization.

8. Severe infectious complications [30 days after randomization]

   To compare the incidence, between groups, of infectious complications defined as a new septic shock.

9. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Intensive Care Unit of the Cancer Institute of Sao Paulo State	Sao Paulo	SP	Brazil	01246000

Sponsors and Collaborators

• University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ludhmila Abrahão Hajjar, Principal Investigator, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT01946269
• Other Study ID Numbers: GRICS-02
• First Posted: Sep 19, 2013
• Last Update Posted: Sep 19, 2013
• Last Verified: Sep 1, 2013

Study Results

No Results Posted as of Sep 19, 2013