Clinical trial · Interventional
Goal-Directed Therapy in Cancer Surgery
Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study
NCT01946269CI-TRIAL-00012182GRICS IIunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Care | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goal-directed Resuscitation Therapy (GDT) | Other | — | UNRESOLVED |
| Standard protocol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard group
- interventionNames
- Other: Standard protocol
- type
- ACTIVE_COMPARATOR
- label
- Goal-directed therapy (GDT) protocol
- interventionNames
- Other: Goal-directed Resuscitation Therapy (GDT)
Primary outcomes (1)
- measure
- Composite endpoint of death or major postoperative complications
- timeFrame
- 30 days after randomization
- description
- Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGerent ARM, Almeida JP, Fominskiy E, Landoni G, de Oliveira GQ, Rizk SI, Fukushima JT, Simoes CM, Ribeiro U Jr, Park CL, Nakamura RE, Franco RA, Candido PI, Tavares CR, Camara L, Dos Santos Rocha Ferreira G, de Almeida EPM, Filho RK, Galas FRBG, Hajjar LA. Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis. Crit Care. 2018 May 23;22(1):133. doi: 10.1186/s13054-018-2055-4. PMID 29792232