Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy

NCT02978430 | Completed Phase 2

• 1 other identifier: P2016/334
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the implementation of computer-assisted goal directed fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.

Conditions

Major Abdominal Surgery

Keywords

Fluid therapy; Anesthesiology; Major surgery; Goal-directed fluid therapy; Fluid responsiveness; Closed-loop system

Outcome Measures

Primary Outcomes (1)

• Perioperative fluid administration

  Fluid balance during perioperative period

  24 hours

Secondary Outcomes (8)

• Length of hospitalisation

  Every day up to 90 days after hospitalization

• Mortality rate

  30 days

• Transfusion of blood products during hospitalization

  Every day up to 90 days post surgery

• Hypotension incidence during surgery

  24 hours

• Need of vasopressor

  24 hours

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

This group (started retrospectively before the first included patient of the closed-loop goal-directed fluid therapy group) consists of patients undergoing major abdominal surgery where fluid management is carried out based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output).

Other: Standard of care

Computer-assisted GDFT

ACTIVE COMPARATOR

This group consists of patients undergoing major abdominal surgery where fluid management is carried out with a closed-loop (automated) system to deliver fluid by a goal-directed fluid therapy (GDFT) standardized protocol. Confer: "Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999)

Device: Computer-assisted GDFT

Interventions

Computer-assisted GDFT DEVICE

Patients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor.

Computer-assisted GDFT

Standard of care OTHER

Patients receive fluid management based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). This control group (started retrospectively before the first included patient of the closed-loop goal directed fluid therapy group) consists of the same population undergoing the same surgery as the closed-loop GDFT group.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (over the age of 18) undergoing elective major abdominal surgery that is expected to take longer than 3 hours and requiring general anesthesia.

You may not qualify if:

• Patients under 18 years of age
• Patients not undergoing surgery, requiring anesthesia, or cardiac output monitoring
• Patients with arrhythmia and/or atrial fibrillation
• Patients who are allergic to HES (hydroxyethyl starch)
• Patients with renal insufficiency (serum creatinine of \>2 mg/ml) or hepatic dysfunction (liver enzymes \>1.5)
• Patients who has coagulation disorders (values higher than 1.5x normal values)
• Patients without the capacity to give written informed consent or refusal of consent
• Pregnancy at time of enrollment.

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

Location

Related Publications (5)

• Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5.

  PMID: 23558909 BACKGROUND

• Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.

  PMID: 24010849 BACKGROUND

• Spanjersberg WR, Bergs EA, Mushkudiani N, Klimek M, Schipper IB. Protocol compliance and time management in blunt trauma resuscitation. Emerg Med J. 2009 Jan;26(1):23-7. doi: 10.1136/emj.2008.058073.

  PMID: 19104091 BACKGROUND

• 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: 25888403 BACKGROUND

• Joosten A, Coeckelenbergh S, Delaporte A, Ickx B, Closset J, Roumeguere T, Barvais L, Van Obbergh L, Cannesson M, Rinehart J, Van der Linden P. Implementation of closed-loop-assisted intra-operative goal-directed fluid therapy during major abdominal surgery: A case-control study with propensity matching. Eur J Anaesthesiol. 2018 Sep;35(9):650-658. doi: 10.1097/EJA.0000000000000827.

  PMID: 29750699 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 1, 2016
• Study Start: April 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 13, 2017

Record last verified: 2016-11

Locations

BE (1)