NCT02739399

Brief Summary

In patients under general anesthesia, episodes of hypotension are often treated with phenylephrine. The effect of phenylephrine is conventionally attributed to afterload increase. The aim of the study is to describe the time course of the effects of phenylephrine on the cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive alpha-mimetic, could be beneficial for preload optimisation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

5 months

First QC Date

April 6, 2016

Last Update Submit

December 8, 2016

Conditions

Arterial HypotensionAnaesthesia

Keywords

phenylephrinealpha mimeticspulse pressure variationvenous return

Outcome Measures

Primary Outcomes (1)

  • Cardiac output

    The evolution of the Cardiac Output in a time course \<20 minutes after administration

    perioperative

Secondary Outcomes (4)

  • Pulse Pressure Variation

    perioperative

  • End-Tidal CO2

    perioperative

  • Arterial Blood Pressure

    perioperative

  • central venous pressure

    perioperative

Study Arms (1)

Patient receiving phenylephrine 2ug/kg

OTHER

phenylephrine 2ug/kg in case of hypotension

Drug: Phenylephrine

Interventions

PhenylephrineDRUG

Intravenous administration

Also known as: Phenyl
Patient receiving phenylephrine 2ug/kg

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult
  • necessity for arterial blood pressure monitoring
  • necessity for central venous blood pressure monitoring

You may not qualify if:

  • unwilling or unable to grant written informed consent
  • cardiac arrythmia
  • contra-indication for phenylephrine
  • contra-indications for atropine
  • contra-indication for Total Intravenous Anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Alain F Kalmar, MD, PhD

    Department of Anaesthesiology and Intensive care medicine, Maria Middelares hospital, Ghent, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 15, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

December 9, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)