Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy

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

PHASE2

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-01-31

Brief Summary

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The aim of this study is to compare the implementation of computer-assisted goal directed fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.

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Detailed Description

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Fluid therapy is one of the main tools used in anesthesiology to maintain adequate hemodynamic stability. Goal-directed fluid therapy (GDFT) based on cardiac output and/or dynamic parameters of fluid responsiveness (e.g. pulse pressure variation) has been shown to decrease post-operative complications. The main inconvenience of protocol based therapy is its technical complexity which requires considerable time, attention, and vigilance. GDFT assisted by a closed-loop system, when compared to manual GDFT, is associated with a longer preload independent state and could increase clinician adherence to protocol. To this day no study has compared closed-loop assisted GDFT to standard of care.

Goal:

This study compares the results of the study entitled "Crystalloids or Colloids for Goal directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999) to a standard of care group (started retrospectively before the first included patient of the above study) where fluid therapy is based only on static variables (e.g. arterial pressure, heart rate, central venous pressure (CVP), and urine output.) These groups consisted of the same population undergoing the same types of surgery.

Hypothesis:

A protocolized approach using computer-assisted GDFT when compared to standard of care is associated with less fluid administration and less blood transfusions.

Conditions

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Major Abdominal Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard of care

This group (started retrospectively before the first included patient of the closed-loop goal-directed fluid therapy group) consists of patients undergoing major abdominal surgery where fluid management is carried out based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output).

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Patients receive fluid management based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). This control group (started retrospectively before the first included patient of the closed-loop goal directed fluid therapy group) consists of the same population undergoing the same surgery as the closed-loop GDFT group.

Computer-assisted GDFT

This group consists of patients undergoing major abdominal surgery where fluid management is carried out with a closed-loop (automated) system to deliver fluid by a goal-directed fluid therapy (GDFT) standardized protocol.

Confer: "Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999)

Group Type ACTIVE_COMPARATOR

Computer-assisted GDFT

Intervention Type DEVICE

Patients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor.

Interventions

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Computer-assisted GDFT

Patients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor.

Intervention Type DEVICE

Standard of care

Patients receive fluid management based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). This control group (started retrospectively before the first included patient of the closed-loop goal directed fluid therapy group) consists of the same population undergoing the same surgery as the closed-loop GDFT group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (over the age of 18) undergoing elective major abdominal surgery that is expected to take longer than 3 hours and requiring general anesthesia.

Exclusion Criteria

* Patients under 18 years of age
* Patients not undergoing surgery, requiring anesthesia, or cardiac output monitoring
* Patients with arrhythmia and/or atrial fibrillation
* Patients who are allergic to HES (hydroxyethyl starch)
* Patients with renal insufficiency (serum creatinine of \>2 mg/ml) or hepatic dysfunction (liver enzymes \>1.5)
* Patients who has coagulation disorders (values higher than 1.5x normal values)
* Patients without the capacity to give written informed consent or refusal of consent
* Pregnancy at time of enrollment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No