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

Primary Peritoneal Neoplasm Clinical Trial

Official title:

Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882920
• Other study ID #: 89/10
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: April 25, 2017
• Start date: June 2010
• Est. completion date: September 2012

Study information

• Verified date: April 2017
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Neoplasm
• Secondary Peritoneal Neoplasm

Intervention

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.
• Conventional Intravenous Fluid therapy
Basal infusion of crystalloid (normal saline,Ringer's lactate,Ringer's solution)variable from 4 to 12 ml/kg/hour.

Locations

Country	Name	City	State
Italy	Regina Elena CI	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	length of hospital stay		4 weeks
Primary	rate of abdominal complications		90 day postoperative complication
Secondary	Overall Survival		90 day overall survival