Correlation Between ΔPP/HR and ΔSV During Fluid Challenge.

Hypovolemia Clinical Trial

— ?PP/HRvs?SV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02439242
• Other study ID #: ?PP/HR vs ?SV
• Status: Recruiting
• Phase: N/A
• First received: April 2, 2015
• Last updated: May 7, 2015
• Start date: June 2014
• Est. completion date: November 2015

Study information

• Verified date: May 2015
• Source: University Hospital, Caen
• Contact: Olivier REBET
• Phone: 33231064736
• Email: rebet-o[@]chu-caen.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypovolemia

Intervention

Drug:
• fluid challenge of saline
250 ml of saline

Locations

Country	Name	City	State
France	CAEN University Hospital	Caen	Basse Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation by linear regression between variations of the ratio PP/HR ( in percentage) and variations of SV ( in percentage) during fluid challenge		18 months	No
Secondary	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	No