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

NCT01882920 | Completed

• 1 other identifier: 89/10
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Peritoneal Neoplasm; Secondary Peritoneal Neoplasm

Keywords

Cytoreductive surgery; hyperthermic intraperitoneal chemotherapy; Goal directed fluid therapy

Outcome Measures

Primary Outcomes (1)

• rate of abdominal complications

  90 day postoperative complication

Secondary Outcomes (1)

• Overall Survival

  90 day overall survival

Other Outcomes (1)

• length of hospital stay

  4 weeks

Study Arms (2)

Goal directed therapy intravenous restricitve fluid protocol

EXPERIMENTAL

Drug: Goal Directed Intravenous Restrictive Fluid Therapy

Control arm

ACTIVE COMPARATOR

Drug: Conventional Intravenous Fluid therapy

Interventions

Goal Directed Intravenous Restrictive Fluid Therapy DRUG

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.

Also known as: Normal Saline, Ringer's lactate, Ringer's solution, Hydroxyethyl starch 130/0,4 (HES 130,04), Automated pulse contour

Goal directed therapy intravenous restricitve fluid protocol

Conventional Intravenous Fluid therapy DRUG

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

Also known as: Normal saline, Ringer's lactate, Ringer's solution

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients selected for Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

You may not qualify if:

• Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

Regina Elena CI

Rome, 00144, Italy

Location

MeSH Terms

Interventions

Saline Solution; Ringer's Lactate; Ringer's Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ester Forastiere, M.D.

  Regina Elena CI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Chief of Critical Area Department

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 21, 2013
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

IT (1)