Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery

Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery: a Pilot Randomized Controlled Trial

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Closed-Loop GDFT; Patients receive fluids in the form of 100ml boluses of crystalloid (Plasmalyte) over 6 minutes via an automated closed-loop goal-directed fluid therapy (GDFT) system guided by non-invasive flow monitoring (Clearsight system). Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .
Active Comparator: 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.	Other: Restrictive Fluid Therapy; Patients receive fluids (Plasmalyte) via a restrictive approach with a baseline of of 4ml/kg/h. Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional fluids administered intraoperatively		6 hours
Number of closed-loop override by the attending anesthesiologist		6 hours
Hospital length of stay		up to 90 days post surgery
Postoperative complications	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.	up to 90 days after hospitalization

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Publications and helpful links

General Publications

• Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. doi: 10.1378/chest.07-0621. Epub 2007 Oct 9.
• Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
• Rinehart J, Lilot M, Lee C, Joosten A, Huynh T, Canales C, Imagawa D, Demirjian A, Cannesson M. Closed-loop assisted versus manual goal-directed fluid therapy during high-risk abdominal surgery: a case-control study with propensity matching. Crit Care. 2015 Mar 19;19(1):94. doi: 10.1186/s13054-015-0827-7.
• Joosten A, Raj Lawrence S, Colesnicenco A, Coeckelenbergh S, Vincent JL, Van der Linden P, Cannesson M, Rinehart J. Personalized Versus Protocolized Fluid Management Using Noninvasive Hemodynamic Monitoring (Clearsight System) in Patients Undergoing Moderate-Risk Abdominal Surgery. Anesth Analg. 2019 Jul;129(1):e8-e12. doi: 10.1213/ANE.0000000000003553.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Fluid therapy; Anesthesiology; Goal-directed fluid therapy; Closed-loop system; Hemodynamic flow monitoring
• Other Study ID Numbers: P2016/526