Back to resultsGoal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)
Primary Purpose
Primary Peritoneal Neoplasm, Secondary Peritoneal Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Goal Directed Intravenous Restrictive Fluid Therapy
Conventional Intravenous Fluid therapy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Peritoneal Neoplasm focused on measuring Cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, Goal directed fluid therapy
Eligibility 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
Sites / Locations
- Regina Elena CI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Goal directed therapy intravenous restricitve fluid protocol
Control arm
Arm Description
Outcomes
Primary Outcome Measures
rate of abdominal complications
Secondary Outcome Measures
Overall Survival
Full Information
NCT ID
NCT01882920
First Posted
June 10, 2013
Last Updated
April 25, 2017
Sponsor
Regina Elena Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01882920
Brief Title
Goal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)
Official Title
Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regina Elena Cancer Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Peritoneal Neoplasm, Secondary Peritoneal Neoplasm
Keywords
Cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, Goal directed fluid therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Goal directed therapy intravenous restricitve fluid protocol
Arm Type
Experimental
Arm Title
Control arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Goal Directed Intravenous Restrictive Fluid Therapy
Other Intervention Name(s)
Normal Saline, Ringer's lactate, Ringer's solution, Hydroxyethyl starch 130/0,4 (HES 130,04), Automated pulse contour
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Conventional Intravenous Fluid therapy
Other Intervention Name(s)
Normal saline, Ringer's lactate, Ringer's solution
Intervention Description
Basal infusion of crystalloid (normal saline,Ringer's lactate,Ringer's solution)variable from 4 to 12 ml/kg/hour.
Primary Outcome Measure Information:
Title
rate of abdominal complications
Time Frame
90 day postoperative complication
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
90 day overall survival
Other Pre-specified Outcome Measures:
Title
length of hospital stay
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester Forastiere, M.D.
Organizational Affiliation
Regina Elena CI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regina Elena CI
City
Rome
ZIP/Postal Code
00144
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Goal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)
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