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

This study is currently recruiting participants.
Verified November 2012 by University Hospital, Caen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01730820
First received: November 16, 2012
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Hypotension

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • cardiac output [ Time Frame: one year ] [ Designated as safety issue: No ]
    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%.


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

General anesthesia.Orotracheal intubation and mechanical ventilation Advanced Hemodynamic Monitoring intraoperative ( arterial pressure catheter, esophageal Doppler)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730820

Contacts
Contact: Olivier REBET, M.D +336111751 rebet-o@chu-caen.fr
Contact: Jean Luc FELLAHI, M.D;Ph.D fellahi-jl@chu-caen.fr

Locations
France
CAEN University Hospital Recruiting
Caen, Basse Normandie, France, 1400
Contact: Olivier REBET, M.D     +33611131751     rebet-o@chu-caen.fr    
Contact: Jean Luc FELLAHI, M.D;Ph.D         fellahi-jl@chu-caen.fr    
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Olivier REBET, M.D University Hospital, Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01730820     History of Changes
Other Study ID Numbers: NEO CO, A12-D20-VOL12
Study First Received: November 16, 2012
Last Updated: November 20, 2012
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013