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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Regina Elena Cancer Institute
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute Identifier:
First received: June 10, 2013
Last updated: April 6, 2016
Last verified: April 2016
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.

Condition Intervention
Primary Peritoneal Neoplasm
Secondary Peritoneal Neoplasm
Drug: Goal Directed Intravenous Restrictive Fluid Therapy
Drug: Conventional Intravenous Fluid therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study

Resource links provided by NLM:

Further study details as provided by Regina Elena Cancer Institute:

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

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

Other Outcome Measures:
  • length of hospital stay [ Time Frame: 4 weeks ]

Estimated Enrollment: 80
Study Start Date: June 2013
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Goal directed therapy intravenous restricitve fluid protocol Drug: Goal Directed Intravenous Restrictive Fluid Therapy
Basal infusion of crystalloids (normal saline,Ringer's lactate,Ringer's solution) at 4 ml/kg/h and boluses of colloids (HES 130/0.4 ) for values of cardiac index (CI) <2.5 l/min/m2, stroke volume index (SVI) < 35 SVI ml/m2 and stroke volume variation (SVV)> 15%. In the case of CI <2.5 l/min/m2 and SVI <35 ml/m2 with SVV < 15%, an infusion with dopamine was initiated.
Other Names:
  • Normal Saline
  • Ringer's lactate
  • Ringer's solution
  • Hydroxyethyl starch 130/0,4 (HES 130,04)
  • Automated pulse contour
Active Comparator: Control arm Drug: Conventional Intravenous Fluid therapy
Basal infusion of crystalloid (normal saline,Ringer's lactate,Ringer's solution)variable from 4 to 12 ml/kg/hour.
Other Names:
  • Normal saline
  • Ringer's lactate
  • Ringer's solution


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01882920

Contact: Ester Forastiere, M.D.

Regina Elena CI Recruiting
Rome, Italy, 00144
Contact: Ester Forastiere, M.D.   
Principal Investigator: Ester Forastiere, M.D.         
Sponsors and Collaborators
Regina Elena Cancer Institute
Principal Investigator: Ester Forastiere, M.D. Regina Elena CI
  More Information

Responsible Party: Ester Forastiere, M.D., Chief of Critical Area Department, Regina Elena Cancer Institute Identifier: NCT01882920     History of Changes
Other Study ID Numbers: 89/10
Study First Received: June 10, 2013
Last Updated: April 6, 2016

Keywords provided by Regina Elena Cancer Institute:
Cytoreductive surgery
hyperthermic intraperitoneal chemotherapy
Goal directed fluid therapy

Additional relevant MeSH terms:
Peritoneal Neoplasms
Body Temperature Changes
Signs and Symptoms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Pharmaceutical Solutions processed this record on March 28, 2017