Critical IllnessCOTRADILNCT04319965
Complications Related to Transpulmonary Thermodilution
An observational study of Critical Illness and Hemodynamic Instability, run by Bicetre Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Hemodynamic Instability, Septic Shock
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in ICU or intermediate care units and in OR, monitoring by TPTD system
Who may be able to join
- Age ≥ 18 years
- Monitoring by a TPTD system (PiCCO2 or VolumeView/EV1000) already planned or set up
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Bicetre Hospital
Paris, Val-de-Marne, 94270
Xavier Monnet, MD. PhD, 331 45 21 35 39, xavier.monnet@aphp.fr
About this study
Official title: Complications Related to Transpulmonary Thermodilution in the Intensive Care Unit and the Operating Room
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.
Read the detailed description
Transpulmonary thermodilution (TPTD) is a technique used for haemodynamic monitoring. It consists of a monitor device which is connected to two catheters. One is a catheter inserted into the superior vena cava (internal jugular or subclavian), which is a standard catheter commonly used in patients with acute circulatory failure. The other one is a thermistor-tipped arterial catheter, which is inserted through the femoral route (the tip stands in the iliac artery), which allows the measurement of blood temperature. Catheters designed for the radial, brachial and humeral arteries also exist. TPTD allows the computation of cardiac output from the thermodilution curve recorded by the thermistor-tipped femoral arterial catheter. As an advanced cardiac output monitoring technique, it provides several important haemodynamic variables. It can be used in the intensive care unit (ICU) and in the operating room (OR). Two TPTD systems are now on the market. The PiCCO2 system (Pulsion Medical Systems, member of the Getinge Group, Feldkirchen, Germany) and the VolumeView/EV1000 system (Edwards Lifesciences, Irvine, United States of America). This study is designed to investigate the incidence of complications and their risk factors in patients monitored by transpulmonary thermodilution.
- Conditions
- Critical Illness, Hemodynamic Instability, Septic Shock, Acute Respiratory Distress Syndrome
- Keywords
- Hemodynamic monitoring, Transpulmonary Thermodilution, Intensive care unite, Operating room, Complications of catheters
- Medical subject headings
- Critical Illness, Shock, Septic, Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the incidence of transpulmonary thermodilution related complications
Systematic report of mechanical, haemorragic and infections complications
Measured: 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.
Systematic report of morphologic characteristics, coagulation, immunity
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start8 Feb 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bicetre Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Monnet, Bicetre Hospital
- Investigators
- Xavier Monnet, MD.PhD, Study chair, Medical intensive care unit; Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319965
- Sponsor's protocol ID
- 2018-A03234-51
- Acronym
- COTRADIL
- Status last verified
- May 2022
- First submitted
- 13 Mar 2020
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22806214Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5.
PubMed 28625165Jozwiak 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.
PubMed 26546321Vincent 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.
PubMed 21884645Cecconi 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.
PubMed 25392034Belda 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.
PubMed 21205627
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications Related to Transpulmonary Thermodilution in the Intensive Care Unit and the Operating Room
- ClinicalTrials.gov ID
- NCT04319965
- Acronym / sponsor ID
- COTRADIL / 2018-A03234-51
- Conditions
- Critical Illness, Hemodynamic Instability, Septic Shock, Acute Respiratory Distress Syndrome
- Keywords
- Hemodynamic monitoring, Transpulmonary Thermodilution, Intensive care unite, Operating room, Complications of catheters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Bicetre HospitalUniversity, hospital or other
- Study start
- 8 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Transpulmonary thermodilution (TPTD) is a technique used for haemodynamic monitoring. It consists of a monitor device which is connected to two catheters. One is a catheter inserted into the superior vena cava (internal jugular or subclavian), which is a standard catheter commonly used in patients with acute circulatory failure. The other one is a thermistor-tipped arterial catheter, which is inserted through the femoral route (the tip stands in the iliac artery), which allows the measurement of blood temperature. Catheters designed for the radial, brachial and humeral arteries also exist. TPTD allows the computation of cardiac output from the thermodilution curve recorded by the thermistor-tipped femoral arterial catheter. As an advanced cardiac output monitoring technique, it provides several important haemodynamic variables. It can be used in the intensive care unit (ICU) and in the operating room (OR). Two TPTD systems are now on the market. The PiCCO2 system (Pulsion Medical Systems, member of the Getinge Group, Feldkirchen, Germany) and the VolumeView/EV1000 system (Edwards Lifesciences, Irvine, United States of America). This study is designed to investigate the incidence of complications and their risk factors in patients monitored by transpulmonary thermodilution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU or intermediate care units and in OR, monitoring by TPTD system
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Monitoring by a TPTD system (PiCCO2 or VolumeView/EV1000) already planned or set up
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe the incidence of transpulmonary thermodilution related complications
Time frame: At the time of TPTD catheters removal, an average of 7-14 days, depending on the individual situation
Systematic report of mechanical, haemorragic and infections complications
1 secondary outcome
Prevalence of theoretical risk factors for these complications.
Time frame: Through study completion, up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Background: PubMed 22806214Sakka 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.
- Background: PubMed 28625165Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5.
- Background: PubMed 26546321Jozwiak 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.
- Background: PubMed 21884645Vincent 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.
- Background: PubMed 25392034Cecconi 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.
- Background: PubMed 21205627Belda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Monnet, MD.PhD study chair
Medical intensive care unit; Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Hemodynamic Instability, run by Bicetre Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier Monnet, MD.PhD (331 45 21 35 39, xavier.monnet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the incidence of transpulmonary thermodilution related complications (time frame: At the time of TPTD catheters removal, an average of 7-14 days, depending on the individual situation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04319965, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.