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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730820
• Other study ID #: NEO CO
• Secondary ID: A12-D20-VOL12
• Status: Completed
• Phase: N/A
• First received: November 16, 2012
• Last updated: September 12, 2014
• Start date: November 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2014
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypotension

Locations

Country	Name	City	State
France	CAEN University Hospital	Caen	Basse Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	one year	No