Correlation Between ΔPP/HR and ΔSV During Fluid Challenge. (ΔPP/HRvsΔSV)

May 7, 2015 updated by: University Hospital, Caen

Correlation Between the Pulse Pressure / Heart Rate Ratio Variations and Stroke Volume Variations During Fluid Challenge.

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%.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse Normandie
      • Caen, Basse Normandie, France, 1400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation by linear regression between variations of the ratio PP/HR ( in percentage) and variations of SV ( in percentage) during fluid challenge
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
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%
Time Frame: 18 month
18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Olivier REBET, CHU Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ΔPP/HR vs ΔSV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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