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

Regina Elena Cancer Institute

Status: Completed

Conditions: Primary Peritoneal Neoplasm; Secondary Peritoneal Neoplasm

Treatments: Drug: Goal Directed Intravenous Restrictive Fluid Therapy; Drug: Conventional Intravenous Fluid therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01882920

89/10

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Goal directed therapy intravenous restricitve fluid protocol

Experimental group

Treatment:

Drug: Goal Directed Intravenous Restrictive Fluid Therapy

Control arm

Active Comparator group

Treatment:

Drug: Conventional Intravenous Fluid therapy