NCT05193097

Brief Summary

Is is debated whether administration of pure vasopressor may augment cardiac output (CO) by means of preload modulation. We wish to test this in 20 patients under general anesthesia, with preload dependency induced by head-up-tilt and preload modulation with infusion of phenylephrine. To document any changes in CO the patients will be monitored by Lithium dilution method. Furthermore we will monitor changes in peripheral perfusion index and test the ability of this non-invasive modality to track changes in CO.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

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

First Submitted

Initial submission to the registry

December 31, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

January 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

December 31, 2021

Last Update Submit

December 31, 2021

Conditions

Anesthesia

Keywords

monitoringcardiac outputperfusion index

Outcome Measures

Primary Outcomes (2)

  • Changes in cardiac output

    30 minutes

  • Changes in peripheral perfusion index

    30 minutes

Eligibility Criteria

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

Cohort of patient with planned surgery under general anesthesia

You may qualify if:

  • Planned surgery under general anesthesia

You may not qualify if:

  • atrial fibrillation
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hojlund J, Cihoric M, Foss NB. Vasoconstriction with phenylephrine increases cardiac output in preload dependent patients. J Clin Monit Comput. 2024 Oct;38(5):997-1002. doi: 10.1007/s10877-024-01186-7. Epub 2024 Jun 21.

    PMID: 38907106DERIVED

Study Officials

  • Jakob Højlund, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Højlund, MD

CONTACT

25708807jakob.hoejlund@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor, consultant

Study Record Dates

First Submitted

December 31, 2021

First Posted

January 14, 2022

Study Start

January 3, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

January 14, 2022

Record last verified: 2021-12