NCT01882075

Brief Summary

The investigators want to test during anesthesia the feasibility of a closed-loop automated fluid replacement system using cardiac output monitoring as the input value.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

June 18, 2013

Last Update Submit

October 28, 2016

Conditions

Anesthesia

Keywords

AnesthesiaFluid administrationClosed-loop

Outcome Measures

Primary Outcomes (1)

  • Mean cardiac output index during the surgery

    One day after anesthesia

Secondary Outcomes (5)

  • Time before reaching maximizing cardiac output

    One day after anesthesia

  • Volume of fluid replacement during surgery

    One day after anesthesia

  • cardiac index during the surgery

    One day after anesthesia

  • arterial hypertension

    One day after anesthesia

  • Dysfunction of the closed-loop fluid device

    One day after anesthesia

Study Arms (2)

Open loop

ACTIVE COMPARATOR

fluid replacement (hydroxyethyl starch 130/0.4) is decided by the physicians according to continuous cardiac output measured by LidCO rapid device

Drug: Open loop

Closed-loop

EXPERIMENTAL

Fluid replacement is automated. An algorithm has been developed ; the input value is continuous cardiac output measured by LidCO rapid device; the computer steers iv infusion of hydroxyethyl starch 130/0.4.

Device: Closed-loop

Interventions

Open loopDRUG
Also known as: fluid replacement by Voluven(hydroxyethyl starch 130/0.4)
Open loop
Closed-loopDEVICE
Also known as: fluid replacement by Voluven (hydroxyethyl starch 130/0.4) is automated (closed-loop)
Closed-loop

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18-75 years
  • Scheduled for abdominal surgery under general anesthesia and requiring an invasive arterial blood pressure monitoring
  • Consenting to participate in the study

You may not qualify if:

  • Pregnant, breast feeding women
  • Allergy
  • Pacemaker
  • Psychiatric disease, dementia, brain disease
  • Contraindication to hydroxyethyl starch
  • Inability to measure pulse pressure variability : arrhythmia, spontaneous breathing, or tidal volume \< 7 ml/Kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 20, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

FR(1)