HypovolemiaΔPP/HRvsΔSVNCT02439242
Correlation Between ΔPP/HR and ΔSV During Fluid Challenge.
An observational study of Hypovolemia, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemia
- What is being tested?
- fluid challenge of saline
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General anaesthesia.Orotracheal intubation and mechanical ventilation Advanced Haemodynamic Monitoring intraoperative ( arterial pressure catheter, oesophageal Doppler)
Who may be able to join
- 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.
Who cannot join
- Minor or major patient under guardianship,
- oesophageal Diseases
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CAEN University Hospital
Caen, Basse Normandie, 1400
Olivier REBET, M.D, +33611131751, rebet-o@chu-caen.fr
Jean Luc HANOUZ, M.D;Ph.D, hanouz-jl@chu-caen.fr
About this study
Official title: 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%.
- Conditions
- Hypovolemia
- Being tested
- fluid challenge of saline
- Keywords
- stroke volume, haemodynamic, fluid resucitation
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid challenge of salineDrug
Also called ΔPP/HR and ΔSV
250 ml of saline
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation by linear regression between variations of the ratio PP/HR ( in percentage) and variations of SV ( in percentage) during fluid challenge
Measured: 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%
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startJun 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier REBET, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439242
- Sponsor's protocol ID
- ΔPP/HR vs ΔSV
- Acronym
- ΔPP/HRvsΔSV
- Status last verified
- May 2015
- First submitted
- 2 Apr 2015
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Pulse Pressure / Heart Rate Ratio Variations and Stroke Volume Variations During Fluid Challenge.
- ClinicalTrials.gov ID
- NCT02439242
- Acronym / sponsor ID
- ΔPP/HRvsΔSV / ΔPP/HR vs ΔSV
- Conditions
- Hypovolemia
- Keywords
- stroke volume, haemodynamic, fluid resucitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General anaesthesia.Orotracheal intubation and mechanical ventilation Advanced Haemodynamic Monitoring intraoperative ( arterial pressure catheter, oesophageal Doppler)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Minor or major patient under guardianship,
- oesophageal Diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluid challenge of salineAlso: ΔPP/HR and ΔSV250 ml of saline | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier REBET principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovolemia, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier REBET (33231064736, rebet-o@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.