NCT04319965

Brief Summary

The transpulmonary thermodilution is commonly used in patients with acute circulatory failure in the intensive care unit and for monitoring surgical patients at high risk. However, the incidence of complications and their risk factors in patients monitored by transpulmonary thermodilution has not been completely reported yet.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration 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 8, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2.9 years

First QC Date

March 13, 2020

Last Update Submit

May 26, 2022

Conditions

Critical IllnessHemodynamic InstabilitySeptic ShockAcute Respiratory Distress Syndrome

Keywords

Hemodynamic monitoringTranspulmonary ThermodilutionIntensive care uniteOperating roomComplications of catheters

Outcome Measures

Primary Outcomes (1)

  • To describe the incidence of transpulmonary thermodilution related complications

    Systematic report of mechanical, haemorragic and infections complications

    At the time of TPTD catheters removal, an average of 7-14 days, depending on the individual situation

Secondary Outcomes (1)

  • Prevalence of theoretical risk factors for these complications.

    Through study completion, up to 1 year

Eligibility Criteria

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

Patients admitted in ICU or intermediate care units and in OR, monitoring by TPTD system

You may qualify if:

  • Age ≥ 18 years
  • Monitoring by a TPTD system (PiCCO2 or VolumeView/EV1000) already planned or set up

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bicetre Hospital

Paris, Val-de-Marne, 94270, France

RECRUITING

Related Publications (6)

  • Sakka SG, Reuter DA, Perel A. The transpulmonary thermodilution technique. J Clin Monit Comput. 2012 Oct;26(5):347-53. doi: 10.1007/s10877-012-9378-5. Epub 2012 Jul 18.

    PMID: 22806214BACKGROUND

  • Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5.

    PMID: 28625165BACKGROUND

  • Jozwiak M, Teboul JL, Monnet X. Extravascular lung water in critical care: recent advances and clinical applications. Ann Intensive Care. 2015 Dec;5(1):38. doi: 10.1186/s13613-015-0081-9. Epub 2015 Nov 6.

    PMID: 26546321BACKGROUND

  • Vincent JL, Rhodes A, Perel A, Martin GS, Della Rocca G, Vallet B, Pinsky MR, Hofer CK, Teboul JL, de Boode WP, Scolletta S, Vieillard-Baron A, De Backer D, Walley KR, Maggiorini M, Singer M. Clinical review: Update on hemodynamic monitoring--a consensus of 16. Crit Care. 2011 Aug 18;15(4):229. doi: 10.1186/cc10291.

    PMID: 21884645BACKGROUND

  • Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.

    PMID: 25392034BACKGROUND

  • Belda FJ, Aguilar G, Teboul JL, Pestana D, Redondo FJ, Malbrain M, Luis JC, Ramasco F, Umgelter A, Wendon J, Kirov M, Fernandez-Mondejar E; PICS Investigators Group. Complications related to less-invasive haemodynamic monitoring. Br J Anaesth. 2011 Apr;106(4):482-6. doi: 10.1093/bja/aeq377. Epub 2010 Dec 26.

    PMID: 21205627BACKGROUND

MeSH Terms

Conditions

Critical IllnessShock, SepticRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSepsisInfectionsSystemic Inflammatory Response SyndromeInflammationShockLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Xavier Monnet, MD.PhD

    Medical intensive care unit; Bicêtre Hospital

    STUDY CHAIR

Central Study Contacts

Xavier Monnet, MD.PhD

CONTACT

331 45 21 35 39xavier.monnet@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Xavier Monnet MD. PhD.

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 24, 2020

Study Start

February 8, 2020

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

FR(1)