Goal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)

Not Applicable

Completed

• Conditions: Primary Peritoneal Neoplasm; Secondary Peritoneal Neoplasm
• Interventions: Drug: Conventional Intravenous Fluid therapy; Drug: Goal Directed Intravenous Restrictive Fluid Therapy

• Registration Number: NCT01882920
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2012-06
• Study Completion: 2012-09
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-21
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Conventional Intravenous Fluid therapy	-
Goal directed therapy intravenous restricitve fluid protocol	Goal Directed Intravenous Restrictive Fluid Therapy	-

Primary Outcome Measures

Name	Time	Method
rate of abdominal complications	90 day postoperative complication

Secondary Outcome Measures

Name	Time	Method
Overall Survival	90 day overall survival

Trial Locations

Locations (1)

Regina Elena CI; 🇮🇹 Rome, Italy