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Completed

NCT Number: NCT01730820

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

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CAEN University Hospital

Caen, Basse Normandie, 1400, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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%.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2012
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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