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

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ClinicalTrials.gov Identifier: NCT01882920
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ester Forastiere, 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.

Condition or disease Intervention/treatment Phase
Primary Peritoneal Neoplasm Secondary Peritoneal Neoplasm Drug: Goal Directed Intravenous Restrictive Fluid Therapy Drug: Conventional Intravenous Fluid therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
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




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

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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882920


Locations
Italy
Regina Elena CI
Rome, Italy, 00144
Sponsors and Collaborators
Regina Elena Cancer Institute
Investigators
Principal Investigator: Ester Forastiere, M.D. Regina Elena CI

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
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Ester Forastiere, 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