NCT03039946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 28, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

January 31, 2017

Last Update Submit

March 27, 2017

Conditions

Abdominal Laparoscopic and/or Robotic Surgery

Keywords

Fluid therapyHemodynamic flow monitoringClosed-loop systemGoal-directed fluid therapyAnesthesiology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

    up to 90 days after hospitalization

Study Arms (2)

Closed-loop GDFT

EXPERIMENTAL

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

Restrictive fluid therapy

ACTIVE COMPARATOR

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

Interventions

Closed-Loop GDFTDEVICE

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) .

Closed-loop GDFT
Restrictive Fluid TherapyOTHER

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) .

Restrictive fluid therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

Location

Related Publications (4)

  • 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.

    PMID: 17925428BACKGROUND

  • 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.

    PMID: 19837807BACKGROUND

  • 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.

    PMID: 25888403BACKGROUND

  • 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.

    PMID: 29878939DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 1, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 28, 2017

Record last verified: 2017-01

Locations

BE(1)