Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery

NCT ID: NCT03039946

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-03-31

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.

Conditions

Abdominal Laparoscopic and/or Robotic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Closed-Loop GDFT

Intervention Type: DEVICE

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) .

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.

Group Type: ACTIVE_COMPARATOR

Restrictive Fluid Therapy

Intervention Type: OTHER

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) .

Interventions

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) .

Intervention Type: DEVICE

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) .

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Erasme University Hospital

Brussels, , Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 17925428 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19837807 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25888403 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29878939 (View on PubMed)

Other Identifiers

P2016/526

Identifier Type: -

Identifier Source: org_study_id