Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery

Not Applicable

Completed

• Conditions: Abdominal Laparoscopic and/or Robotic Surgery
• Interventions: Other: Restrictive Fluid Therapy; Device: Closed-Loop GDFT

• Registration Number: NCT03039946
• Lead Sponsor: Erasme University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restrictive fluid therapy	Restrictive Fluid Therapy	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.
Closed-loop GDFT	Closed-Loop GDFT	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.

Primary Outcome Measures

Name	Time	Method
Preload independent state	6 hours	The percentage intraoperative time spent with stroke volume variation \< 13% and/or cardiac index \> 2.4 L/min/m2

Secondary Outcome Measures

Name	Time	Method
Number of closed-loop override by the attending anesthesiologist	6 hours
Postoperative complications	up to 90 days after hospitalization	Major complications include cardiac (acute coronary syndrome/ arrhythmia), pulmonary (embolism/edema), gastrointestinal (bowel and surgical anastomotic leak/internal or external fistulas/peritoneal effusions), renal (renal failure requiring dialysis), infectious (peritonitis/ sepsis), coagulation (bleeding), wound dehiscence, stroke, reoperation, readmission, and death.; Minor complications include unplanned ICU admission, pneumonia/pleural effusion, deep venous thrombosis, paralytic ileus, renal insufficiency, infection (superficial wound infection/fever/urinary infection) and confusion/delirium.
Additional fluids administered intraoperatively	6 hours
Hospital length of stay	up to 90 days post surgery

Trial Locations

Locations (1)

Erasme University Hospital; 🇧🇪 Brussels, Belgium