HypotensionNCT01730820
Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output
An observational study of Hypotension, run by University Hospital, Caen at 1 site in France.
Trial summary
The perioperative hemodynamic management aims to ensure organ perfusion pressure and an oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic agonist widely used during anesthesia for arterial pressure control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Jul 2013
- 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 anesthesia.Orotracheal intubation and mechanical ventilation Advanced Hemodynamic Monitoring intraoperative ( arterial pressure catheter, esophageal Doppler)
Who may be able to join
- Hypotension (SBP <90 mm Hg and / or MAP <60 mm Hg)
- Injection of a bolus of phenylephrine at the discretion of the anesthesiologist physician in charge of the patient.
Who cannot join
- Minor or major patient under guardianship
- Esophageal Diseases
- supra ventricular rhythm trouble
- Severe valvular
- Shunt intracardiac
- Vt <7ml/kg theoretical weight
Show all 14Show fewer
- heart rate / respiratory rate <3.6
- Clinical hypepression of intra-abdominal
- Compliance <30 mL/cmH2O
- pulmonary hypertension, Right ventricular failure
- Spontaneous Ventilation
- Thorax open
- VG severe dysfunction (LVEF <40%)
- Prior Injection of ephedrine prior
Trial locations and contacts
1 site in 1 country.
About this study
The perioperative hemodynamic management aims to ensure organ perfusion pressure and an oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic agonist widely used during anesthesia for arterial pressure control.
Several questions on phenylephrine global and regional hemodynamics effects remain unresolved.
Read more
The investigators assume that Phenylephrine may decrease cardiac output by increasing the afterload, while most likely could also make an increase or a stability of cardiac output by action on the venous return. The investigators propose an observational study assessing the influence of preload dependence, defined by the values of pulse pressure variation, on the effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler.
The aim of the investigators work is to improve the understanding of phenylephrine action, a daily use therapeutic action, to improve the patients care.
- Conditions
- Hypotension
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output
Comparing cardiac output values before and after injection of a phenylephrine bolus, based on the existence of a preload dependency, defined by a measure of respiratory variation of pulse pressure greater than or equal to 13%.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionJul 2013
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 HypotensionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier REBET, M.D, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730820
- Sponsor's protocol ID
- NEO CO
- Other IDs
- A12-D20-VOL12
- Status last verified
- Sep 2014
- First submitted
- 16 Nov 2012
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rebet O, Andremont O, Gerard JL, Fellahi JL, Hanouz JL, Fischer MO. Preload dependency determines the effects of phenylephrine on cardiac output in anaesthetised patients: A prospective observational study. Eur J Anaesthesiol. 2016 Sep;33(9):638-44. doi: 10.1097/EJA.0000000000000470.
PubMed 27164015
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output
- ClinicalTrials.gov ID
- NCT01730820
- Acronym / sponsor ID
- NEO CO
- Conditions
- Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Nov 2012 (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 perioperative hemodynamic management aims to ensure organ perfusion pressure and an oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic agonist widely used during anesthesia for arterial pressure control.
Several questions on phenylephrine global and regional hemodynamics effects remain unresolved.
The investigators assume that Phenylephrine may decrease cardiac output by increasing the afterload, while most likely could also make an increase or a stability of cardiac output by action on the venous return. The investigators propose an observational study assessing the influence of preload dependence, defined by the values of pulse pressure variation, on the effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler.
The aim of the investigators work is to improve the understanding of phenylephrine action, a daily use therapeutic action, to improve the patients care.
Study design
- 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 anesthesia.Orotracheal intubation and mechanical ventilation Advanced Hemodynamic Monitoring intraoperative ( arterial pressure catheter, esophageal Doppler)
Key inclusion criteria (2 listed)
- Hypotension (SBP <90 mm Hg and / or MAP <60 mm Hg)
- Injection of a bolus of phenylephrine at the discretion of the anesthesiologist physician in charge of the patient.
Key exclusion criteria (14 listed)
- Minor or major patient under guardianship
- Esophageal Diseases
- supra ventricular rhythm trouble
- Severe valvular
- Shunt intracardiac
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiac output
Time frame: one year
Comparing cardiac output values before and after injection of a phenylephrine bolus, based on the existence of a preload dependency, defined by a measure of respiratory variation of pulse pressure greater than or equal to 13%.
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 15 Sep 2014.
- Derived from this study: PubMed 27164015Rebet O, Andremont O, Gerard JL, Fellahi JL, Hanouz JL, Fischer MO. Preload dependency determines the effects of phenylephrine on cardiac output in anaesthetised patients: A prospective observational study. Eur J Anaesthesiol. 2016 Sep;33(9):638-44. doi: 10.1097/EJA.0000000000000470.
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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, M.D 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 Hypotension, 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 14 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 15 Sep 2014. 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?
cardiac output (time frame: one year). 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 NCT01730820, 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 15 Sep 2014.