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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Peritoneal Neoplasm Secondary Peritoneal Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Goal directed therapy intravenous restricitve fluid protocol

Group Type EXPERIMENTAL

Goal Directed Intravenous Restrictive Fluid Therapy

Intervention Type 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.

Control arm

Group Type ACTIVE_COMPARATOR

Conventional Intravenous Fluid therapy

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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