Clinical trial · Interventional
Goal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)
Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study
- 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 aim of the study is to assess whether in cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) the use of a protocol of intravenous fluid therapy combined with goal directed fluid therapy (GDT) is associated with a significant change in morbidity, length of hospital stay and mortality compared to a standard fluid therapy. Patients undergoing CRS and hipec are randomly divided into two treatment groups. The GDT group receive fluid intravenous therapy according to a specific treatment protocol guided by monitored hemodynamic parameters assessed using the arterial pressure signal monitoring to assess stroke volume and cardiac output via an automated pulse contour analysis (Flotrac/Vigileo®); the control group receive the standard fluid therapy (crystalloid and colloid). Fluid therapy regimen is free in the control group and targeted in the GDT group. In both groups, the investigators evaluate the incidence of major abdominal and systemic complications, the total duration of hospital stay, mortality, the total amount of fluids administered, their breakdown (crystalloid/colloid) and the total number of colloid boluses administered.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Peritoneal Neoplasm | — | UNRESOLVED | — |
| Secondary Peritoneal Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Intravenous Fluid therapy | Drug | — | UNRESOLVED |
| Goal Directed Intravenous Restrictive Fluid Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Goal directed therapy intravenous restricitve fluid protocol
- interventionNames
- Drug: Goal Directed Intravenous Restrictive Fluid Therapy
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- interventionNames
- Drug: Conventional Intravenous Fluid therapy
Primary outcomes (1)
- measure
- rate of abdominal complications
- timeFrame
- 90 day postoperative complication
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients selected for Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy Exclusion Criteria: * Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders
References
Publications (0)
Data not yet available