HypovolemiaNCT01258361
Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting
An observational study of Hypovolemia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The primary objective of this study is to demonstrate that preoperative fasting does not increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg lift) in patients undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypovolemia
- What is being tested?
- echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to 13 Apr 2011
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recruited during anesthesia consultations carried out before programmed gynecological or visceral surgeries.
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is ASA (American Society of Anesthesiologists) class I, II or III
- The patient has not been fasting for more than 6 hours at the time of inclusion
- The patient is schelduled for a gynecological or visceral surgery
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant
Show all 16Show fewer
- The patient is breastfeeding
- The patient is ASA class IV
- The patient has insulin dependent diabetes
- The patient has a cardiac or respiratory dysfunction
- The patient has a heart rhythm disorder
- The patient has renal insufficiency with dialysis
- The patient is being treated with diuretics
- The patient has had a bowel preparation
- Emergency surgery
- Outpatient surgery
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to demonstrate that preoperative fasting does not increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg lift) in patients undergoing surgery.
- Conditions
- Hypovolemia
- Being tested
- echocardiography
- Keywords
- preoperative fasting
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyProcedure or surgery
Echocardiography is performed for all patients
| Study group | Role | What they receive |
|---|---|---|
| The study population | Patients will be recruited during anesthesia consultations carried out before programmed pelvic or visceral surgeries. Receives: Procedure: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence / absence of a hypovolemia following preoperative fasting
Hypovolemia is determined by the % change in the subaortic velocity time integral during a leg lift before and after fasting: a 15% decrease is considered as a "presence".
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startJan 2011
- Primary completion13 Apr 2011
- Study completion13 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Muller, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258361
- Sponsor's protocol ID
- LOCAL/2010/LM-03
- Other IDs
- 2010-A01275-34
- Status last verified
- Mar 2015
- First submitted
- 10 Dec 2010
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller L, Briere M, Bastide S, Roger C, Zoric L, Seni G, de La Coussaye JE, Ripart J, Lefrant JY. Preoperative fasting does not affect haemodynamic status: a prospective, non-inferiority, echocardiography study. Br J Anaesth. 2014 May;112(5):835-41. doi: 10.1093/bja/aet478. Epub 2014 Feb 3.
PubMed 24496782
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting
- ClinicalTrials.gov ID
- NCT01258361
- Acronym / sponsor ID
- LOCAL/2010/LM-03
- Conditions
- Hypovolemia
- Keywords
- preoperative fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- 13 Apr 2011 (actual)
- Study completion
- 13 Apr 2011 (actual)
- First posted
- 13 Dec 2010 (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.
The primary objective of this study is to demonstrate that preoperative fasting does not increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg lift) in patients undergoing surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Procedure: echocardiographyPatients will be recruited during anesthesia consultations carried out before programmed pelvic or visceral surgeries. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited during anesthesia consultations carried out before programmed gynecological or visceral surgeries.
Key inclusion criteria (5 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is ASA (American Society of Anesthesiologists) class I, II or III
- The patient has not been fasting for more than 6 hours at the time of inclusion
- The patient is schelduled for a gynecological or visceral surgery
Key exclusion criteria (16 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| echocardiographyEchocardiography is performed for all patients | Procedure or surgery | The study population |
Primary outcome
The presence / absence of a hypovolemia following preoperative fasting
Time frame: 1 day
Hypovolemia is determined by the % change in the subaortic velocity time integral during a leg lift before and after fasting: a 15% decrease is considered as a "presence".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 24496782Muller L, Briere M, Bastide S, Roger C, Zoric L, Seni G, de La Coussaye JE, Ripart J, Lefrant JY. Preoperative fasting does not affect haemodynamic status: a prospective, non-inferiority, echocardiography study. Br J Anaesth. 2014 May;112(5):835-41. doi: 10.1093/bja/aet478. Epub 2014 Feb 3.
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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.
Laurent Muller, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Centre Hospitalier Universitaire de Nīmes 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 17 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence / absence of a hypovolemia following preoperative fasting (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01258361, which also lists 1 linked publication.
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 17 Nov 2025.