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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 November 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: November 5, 2014
Last verified: November 2014

June 10, 2013
November 5, 2014
June 2013
December 2014   (final data collection date for primary outcome measure)
rate of abdominal complications [ Time Frame: 90 day postoperative complication ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01882920 on ClinicalTrials.gov Archive Site
Overall Survival [ Time Frame: 90 day overall survival ] [ Designated as safety issue: No ]
Same as current
length of hospital stay [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
 
Goal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)
Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Peritoneal Neoplasm
  • Secondary Peritoneal Neoplasm
  • 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
  • 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
  • Experimental: Goal directed therapy intravenous restricitve fluid protocol
    Intervention: Drug: Goal Directed Intravenous Restrictive Fluid Therapy
  • Active Comparator: Control arm
    Intervention: Drug: Conventional Intravenous Fluid therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ester Forastiere, M.D. forastiere@ifo.it
Italy
 
NCT01882920
89/10
No
Ester Forastiere, Regina Elena Cancer Institute
Regina Elena Cancer Institute
Not Provided
Principal Investigator: Ester Forastiere, M.D. Regina Elena CI
Regina Elena Cancer Institute
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP