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Goal-Directed Therapy in Cancer Surgery (GRICS II)

U

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

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)

Trial contacts and locations

1

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Central trial contact

Aline Müller, MD

Data sourced from clinicaltrials.gov

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