Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery

Free University of Brussels (ULB)

Status: Completed

Conditions: Abdominal Laparoscopic and/or Robotic Surgery

Treatments: Other: Restrictive Fluid Therapy; Device: Closed-Loop GDFT

Study type: Interventional

Funder types: Other

Identifiers

NCT03039946

P2016/526

Details and patient eligibility

About

The aim of this study is to compare hemodynamic variables and outcome in patients undergoing laparoscopic and/or robotic elective abdominal surgery. Patients will receive either an automated closed-loop goal-directed fluid therapy (GDFT) guided by non-invasive flow monitoring or a restrictive fluid therapy of 4ml/kg/h.

Full description

Perioperative fluid management is a topic of much debate that has intensified over recent years. Studies have shown improved postoperative outcomes with restricted fluid administration in the perioperative period for moderate risk abdominal surgery. They concluded that in patients undergoing elective abdominal surgery, intraoperative restrictive fluid management was associated with a reduction in postoperative morbidity and shortened hospital stay. Current standard practice is a crystalloid based fluid therapy guided by static hemodynamic parameters such as heart rate, blood pressure, and diuresis. However, several studies have criticized this cookbook approach and recommend tailoring management to specific physiologic dynamic endpoints such as stroke volume variation and cardiac output using a flow monitoring device. Our team has demonstrated that the use of a closed-loop system is feasible and allows precise titration of fluid administration in abdominal and vascular surgery using either a minimally or a non-invasive monitoring system.

Goal:

This study compares hemodynamic variables and outcome in patients who will receive either automated closed-loop fluid therapy guided by non-invasive flow monitoring or restrictive fluid therapy of 4ml/kg/h. Both groups consist of the same population undergoing laparoscopic and/or robotic surgery.

Hypothesis:

A closed-loop assisted intraoperative GDFT when compared to restrictive fluid therapy will provide better hemodynamic variables.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Laparoscopic and/or robotic elective abdominal surgery( colorectal, gynecological, urological)

Exclusion criteria

• Intraoperative invasive monitoring (arterial line)
• Open colorectal surgery (laparotomy)
• Emergency surgery
• Expected intraoperative blood loss greater than 1000ml
• Arrhythmia (e.g. atrial fibrillation)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Closed-loop GDFT

Experimental group

Description:

This group consists of patients undergoing laparoscopic and/or robotic abdominal surgery where fluid maintenance with Plasmalyte is carried out using a closed-loop system guided by the Clearsight non-invasive hemodynamic flow monitor.

Treatment:

Device: Closed-Loop GDFT

Restrictive fluid therapy

Active Comparator group

Description:

This group consists of patients undergoing laparoscopic and/or robotic abdominal surgery where fluid management is based on a restrictive (4ml/kg/h) Plasmalyte infusion.

Treatment:

Other: Restrictive Fluid Therapy