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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01882920

Enrollment

Registered

2013-06-21

Start date

2010-06-30

Completion date

2012-09-30

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Peritoneal Neoplasm, Secondary Peritoneal Neoplasm

Keywords

Cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, Goal directed fluid therapy

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.

Interventions

DRUGGoal 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.

DRUGConventional Intravenous Fluid therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
rate of abdominal complications	90 day postoperative complication

Secondary

Measure	Time frame
Overall Survival	90 day overall survival

Other

Measure	Time frame
length of hospital stay	4 weeks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026