NCT04620694

Brief Summary

Choice of arterial cannulation site during cardiac surgery is controversial. Some physicians in our institution prefer radial artery site, others prefer aortic site (via femoral artery or brachial artery). The investigators aim to compare these two strategies for vasopressor requirement. The study hypothesis is that radial artery cannulation is associated with a larger dose of vasopressor due aortic to radial arterial pressure gradient phenomenon.

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
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

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

October 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 3, 2020

Last Update Submit

November 6, 2020

Conditions

Cardiac Disease

Keywords

Cardiac surgeryAortic to radial arterial pressure gradientVasopressor

Outcome Measures

Primary Outcomes (1)

  • Intraoperative vasopressor requirement

    Mean intraoperative dosage of Norepinephrine (µg.kg-1.min-1)

    end of surgery

Study Arms (2)

Radial artery cannulation

Patients whom radial artery was cannulated at the beginning of the surgery.

Aortic cannulation (brachial or femoral artery)

Patients whom femoral or brachial artery was cannulated at the beginning of the surgery. Active comparator

Device: Choice of arterial cannulation site at the beginning of the surgery

Interventions

Choice of arterial cannulation site at the beginning of the surgeryDEVICE

Choice of arterial cannulation site at the beginning of the surgery is at the discretion of the anesthesia physician.

Aortic cannulation (brachial or femoral artery)

Eligibility Criteria

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

Adult patients scheduled for cadiac surgery wih cardiopulmonary bypass

You may qualify if:

  • Adult patient
  • Scheduled for cardiac surgery with cardiopulmonary bypass

You may not qualify if:

  • More than one arterial cannula at the beginning of the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Louis Pradel

Lyon, France

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Remi Schweizer, MD

CONTACT

0033472318933remi.schweizer@chu-lyon.fr

Jean Luc FELLAHI, MD

CONTACT

0033472318933jean-luc.fellahi@chu-lyon.fr

Study Design

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

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

October 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations

FR(1)