Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output

NCT ID: NCT01730820

Last Updated: 2014-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypotension

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Minor or major patient under guardianship
* Esophageal Diseases
* supra ventricular rhythm trouble
* Severe valvular
* Shunt intracardiac
* Vt \<7ml/kg theoretical weight
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier REBET, M.D

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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CAEN University Hospital

Caen, Basse Normandie, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 27164015 (View on PubMed)

Other Identifiers

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A12-D20-VOL12

Identifier Type: OTHER

Identifier Source: secondary_id

NEO CO

Identifier Type: -

Identifier Source: org_study_id

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