Correlation Between ΔPP/HR and ΔSV During Fluid Challenge. | NCT02439242

Studies
Correlation Between ΔPP/HR and ΔSV During Fluid Challenge.

NCT02439242

Sponsor

University Hospital, Caen

Status

Unknown status

Last Update Posted

May 8, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Hypovolemia

Interventions

fluid challenge of saline

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Nov 2015Estimated

Completion Date

Nov 2015Estimated

First Submitted Date

Apr 2, 2015

First Submission Date that Met QC Criteria

May 7, 2015

First Posted Date

May 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2015

Last Update Posted Date

May 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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%.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fluid challenge of saline	Drug	250 ml of saline		ΔPP/HR and ΔSV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Minor or major patient under guardianship,
oesophageal Diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Olivier REBET	Contact	33231064736		rebet-o@chu-caen.fr
Jean Luc Hanouz	Contact	33231064736		hanouz-jl@chu-caen.fr

Overall Officials

Name	Affiliation	Role
Olivier REBET	University Hospital, Caen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CAEN University Hospital	Recruiting	Caen	Basse Normandie	1400	France

Condition Browse Module

MeSH Terms

ID	Term
D020896	Hypovolemia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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