NCT02439242

Brief Summary

In high perioperative risk patients, guidelines suggest intraoperative haemodynamic optimization by measurement of stroke volume (SV) to guide fluid resucitation.This strategy requires an invasive monitoring and learning. Some studies tried to find SV surrogates based on haemodynamic usual parameters. In an experimental hemorrhagic shock, SV was correlated to the pulse pressure (PP) / heart rate (HR) ratio. The investigators hypothesized that SV variations (ΔSV) would be correlated to the PP/HR ratio variations (ΔPP / HR) during fluid challenge, and ΔPP / HR would be able to detect a ΔSV greater than 10%.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

April 2, 2015

Last Update Submit

May 7, 2015

Conditions

Hypovolemia

Keywords

stroke volume, haemodynamic, fluid resucitation

Outcome Measures

Primary Outcomes (1)

  • correlation by linear regression between variations of the ratio PP/HR ( in percentage) and variations of SV ( in percentage) during fluid challenge

    18 months

Secondary Outcomes (1)

  • Area under the receiver operating characteristic curve (AUC roc) of the ability of variations of the ratio PP/HR ( in percentage)during fluid challenge to predict an increase of SV greater than 10%

    18 month

Interventions

fluid challenge of salineDRUG

250 ml of saline

Also known as: ΔPP/HR and ΔSV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General anaesthesia.Orotracheal intubation and mechanical ventilation Advanced Haemodynamic Monitoring intraoperative ( arterial pressure catheter, oesophageal Doppler)

You may qualify if:

  • a suspected hypovolemia, based on clinical or paraclinical parameters.
  • a fluid challenge decision at the discretion of the anaesthesiologist physician in charge of the patient.

You may not qualify if:

  • Minor or major patient under guardianship,
  • oesophageal Diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAEN University Hospital

Caen, Basse Normandie, 1400, France

RECRUITING

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier REBET

    CHU CAEN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier REBET

CONTACT

33231064736rebet-o@chu-caen.fr

Jean Luc Hanouz

CONTACT

33231064736hanouz-jl@chu-caen.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2015

First Posted

May 8, 2015

Study Start

June 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

FR(1)