NCT04772599

Brief Summary

Norepinephrine is the vasopressor of choice for the treatment of peri-anesthetic arterial hypotension. The use of this drug at significantly lower concentrations (dilution factor between 40 and 200) than the commercial preparation is increasingly common in the operating room ("baby-noradrenaline"). In addition, dilution errors are potentially serious for the patient (hypertensive peak) The preparation of precise dilutions is an important factor for the safe use of this medically In this study, the investigators wish to compare the dilution method of the protocol with another method of preparation (left to the free choice of the participant).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 21, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 23, 2021

Last Update Submit

February 23, 2021

Conditions

Arterial Hypertension

Keywords

NoradrenalineNorepinephrineConcentration of noradrenalineVasopressorBaby-noradrenalineDilution of Noradrenaline

Outcome Measures

Primary Outcomes (1)

  • Measurement of noradrenaline concentrations using different dilution methods

    Measurement methods: * High performance liquid chromatography * Measurement of the concentration of noradrenaline in the biochemical laboratory of the University Hospitals of Strasbourg

    1 hour after the preparation of the noradrenaline solutions

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Employee of the University Hospitals of Strasbourg accepting to participate in the study

You may qualify if:

  • Adult person,
  • Employee of Strasbourg University Hospitals,
  • Likely to have to prepare anesthesia drugs in the operating room (intern, hospital student, IADE, IADE student)

You may not qualify if:

  • \- Subject's refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strasbourg University Hospitals - Anesthesia-intensive care unit

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Thiên-Nga CHAMARAUX-TRAN, MD

CONTACT

33 3 88 12 70 75ThienNga.CHAMARAUX-TRAN@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

33 3 88 11 66 90said.chayer@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 26, 2021

Study Start

February 21, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

FR(1)