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 2014 by Regina Elena Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier:
NCT01882920
First received: June 10, 2013
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 90 day overall survival ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • length of hospital stay [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Primary Completion Date: September 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01882920

Contacts
Contact: Ester Forastiere, M.D. forastiere@ifo.it

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

No publications provided

Responsible Party: Ester Forastiere, M.D., Chief of Critical Area Department, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier: NCT01882920     History of Changes
Other Study ID Numbers: 89/10
Study First Received: June 10, 2013
Last Updated: April 24, 2014
Health Authority: Italy: AIFA ("Agenzia italiana per il farmaco")

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

Additional relevant MeSH terms:
Neoplasms
Fever
Peritoneal Neoplasms
Body Temperature Changes
Signs and Symptoms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014