Goal-Directed Therapy in Cancer Surgery (GRICS II)

University of Sao Paulo

Status and phase: Unknown; Phase 3

Conditions: Postoperative Care

Treatments: Other: Goal-directed Resuscitation Therapy (GDT); Other: Standard protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01946269

GRICS-02

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

Standard group

Active Comparator group

Treatment:

Other: Standard protocol

Goal-directed therapy (GDT) protocol

Active Comparator group

Treatment:

Other: Goal-directed Resuscitation Therapy (GDT)