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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study

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 Summary:
Sponsor: Regina Elena Cancer Institute

Current Primary Outcome: rate of abdominal complications [ Time Frame: 90 day postoperative complication ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Overall Survival [ Time Frame: 90 day overall survival ]

Original Secondary Outcome: Same as current

Information By: Regina Elena Cancer Institute

Dates:
Date Received: June 10, 2013
Date Started: June 2010
Date Completion:
Last Updated: April 25, 2017
Last Verified: April 2017