NCT06918301

Brief Summary

A comparison of cardiac performance determined by stroke-volume-index measured by different mechanisms in patients during and after cardiac surgery:

  1. 1.Pulmonary artery catheter
  2. 2.Flo Trac
  3. 3.Argos Monitor Investigations will be done in theater and on ICU in ventilated and spontaneously breathing patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 1, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

April 5, 2025

Conditions

Cardiac Failure AcuteHemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

  • stroke volume index

    stroke volume index

    24 hours

Interventions

Measurement of cardiac performanceDIAGNOSTIC_TEST

Measurement of cardiac performance by different devices

Eligibility Criteria

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

All patients after cardiac surgery requirering a pulmonary artery catheter

You may qualify if:

  • Patient after cardiac surgery with pulmonary artery catheter

You may not qualify if:

  • Hemodynamic instability, no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Anästhesiologie und Intensivmedizin, Klinikum Karlsburg

Karlsburg, 17495, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood gas analysis

Study Officials

  • Matthias Heringlake

    Head of Department of Anesthesiology and intensive care, Karlsburg Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Heringlake

CONTACT

Deutschlandheringlake@t-online.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department of anesthesiology and intensive care

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 9, 2025

Study Start

March 1, 2025

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)