Septic ShockTIPRESNCT05627817
Timing of Preload Responsiveness in Sepsis
An observational study of Septic Shock and Fluid Responsiveness, run by Bicetre Hospital at 1 site in France.
Trial summary
During acute circulatory failure, volume expansion does not always lead to a significant increase in cardiac output (fluid responsiveness). After initial resuscitation by rapid fluid administration, cardiac preload is no longer extremely low and only half of the patients respond to further volume expansion with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Fluid Responsiveness
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2019to Dec 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: The patients who just arrive at the Intensive Care Unit (ICU) for septic shock need to be quickly resuscitated.
Who may be able to join
- Age ≥ 18 ans
- Onset of septic shock
Who cannot join
- Planned to transfer the patient to another healthcare facility (inability to continue cardiac output measurements); urgent operation; Inability to measure the cardiac output.
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: Timing of Preload Responsiveness in Sepsis and Septic Shock
During acute circulatory failure, volume expansion does not always lead to a significant increase in cardiac output (fluid responsiveness). After initial resuscitation by rapid fluid administration, cardiac preload is no longer extremely low and only half of the patients respond to further volume expansion with the expected increase in cardiac output (fluid unresponsiveness). However, the time delay or the volume of fluid needed to be administered from the state of fluid responsiveness to fluid unresponsiveness is still not determined.
Objective To determine, in critically ill patients with acute circulatory failure,
- : the time and/or the volume of fluid needed from the state of fluid responsiveness to fluid unresponsiveness during septic shock.
- : determine the factors that influence this time and volume.
- Conditions
- Septic Shock, Fluid Responsiveness
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
The time delay from the state of fluid responsiveness to fluid unresponsiveness
At the time of inclusion, the investigators use the tests available (fluid challenge, passive leg raising, end-expiratory occlusion test) to evaluate the presence of fluid responsiveness, and after one hour, the investigators repeat the test and to re-evaluate the presence of fluid responsiveness until the patient is no longer present the fluid responsiveness.
Measured: 60 minutes after the evaluation of fluid responsiveness
The volume of fluid needed from the state of fluid responsiveness to fluid unresponsiveness
If the fluid challenge is performed, the volume of each time for the fluid administration should be noted until the patient is no longer fluid-responsive, then the investigators can calculate the total amount of the fluid administrated.
Measured: 15-30 minutes during the fluid administration
Secondary outcomes (2)
The risk factors for the time delay
Determine the factors that may influence the time delay from the state of fluid responsiveness to fluid unresponsiveness
Measured: Through study completion, an average of 1 year
The risk factors for the volume of fluid needed from the state of fluid responsiveness to fluid
Determine the factors that may influence the volume of fluid administrated from the state of fluid responsiveness to fluid unresponsiveness
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start20 Feb 2019
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bicetre Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Xavier Monnet, Bicetre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627817
- Sponsor's protocol ID
- 2018-A03040-55
- Acronym
- TIPRES
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
PubMed 34599691Monnet X, Teboul JL. My patient has received fluid. How to assess its efficacy and side effects? Ann Intensive Care. 2018 Apr 24;8(1):54. doi: 10.1186/s13613-018-0400-z.
PubMed 29691755Monnet X, Shi R, Teboul JL. Prediction of fluid responsiveness. What's new? Ann Intensive Care. 2022 May 28;12(1):46. doi: 10.1186/s13613-022-01022-8.
PubMed 35633423Roger C, Zieleskiewicz L, Demattei C, Lakhal K, Piton G, Louart B, Constantin JM, Chabanne R, Faure JS, Mahjoub Y, Desmeulles I, Quintard H, Lefrant JY, Muller L; AzuRea Group. Time course of fluid responsiveness in sepsis: the fluid challenge revisiting (FCREV) study. Crit Care. 2019 May 16;23(1):179. doi: 10.1186/s13054-019-2448-z.
PubMed 31097012Kattan E, Ospina-Tascon GA, Teboul JL, Castro R, Cecconi M, Ferri G, Bakker J, Hernandez G; ANDROMEDA-SHOCK Investigators. Systematic assessment of fluid responsiveness during early septic shock resuscitation: secondary analysis of the ANDROMEDA-SHOCK trial. Crit Care. 2020 Jan 23;24(1):23. doi: 10.1186/s13054-020-2732-y.
PubMed 31973735
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Preload Responsiveness in Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT05627817
- Acronym / sponsor ID
- TIPRES / 2018-A03040-55
- Conditions
- Septic Shock, Fluid Responsiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bicetre HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Nov 2022 (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.
During acute circulatory failure, volume expansion does not always lead to a significant increase in cardiac output (fluid responsiveness). After initial resuscitation by rapid fluid administration, cardiac preload is no longer extremely low and only half of the patients respond to further volume expansion with the expected increase in cardiac output (fluid unresponsiveness). However, the time delay or the volume of fluid needed to be administered from the state of fluid responsiveness to fluid unresponsiveness is still not determined.
Objective To determine, in critically ill patients with acute circulatory failure,
- : the time and/or the volume of fluid needed from the state of fluid responsiveness to fluid unresponsiveness during septic shock.
- : determine the factors that influence this time and volume.
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
- The patients who just arrive at the Intensive Care Unit (ICU) for septic shock need to be quickly resuscitated.
Key inclusion criteria (2 listed)
- Age ≥ 18 ans
- Onset of septic shock
Key exclusion criteria (1 listed)
- Planned to transfer the patient to another healthcare facility (inability to continue cardiac output measurements); urgent operation; Inability to measure the cardiac output.
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
The time delay from the state of fluid responsiveness to fluid unresponsiveness
Time frame: 60 minutes after the evaluation of fluid responsiveness
At the time of inclusion, the investigators use the tests available (fluid challenge, passive leg raising, end-expiratory occlusion test) to evaluate the presence of fluid responsiveness, and after one hour, the investigators repeat the test and to re-evaluate the presence of fluid responsiveness until the patient is no longer present the fluid responsiveness.
The volume of fluid needed from the state of fluid responsiveness to fluid unresponsiveness
Time frame: 15-30 minutes during the fluid administration
If the fluid challenge is performed, the volume of each time for the fluid administration should be noted until the patient is no longer fluid-responsive, then the investigators can calculate the total amount of the fluid administrated.
2 secondary outcomes
The risk factors for the time delay
Time frame: Through study completion, an average of 1 year
The risk factors for the volume of fluid needed from the state of fluid responsiveness to fluid
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Background: PubMed 34599691Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
- Background: PubMed 29691755Monnet X, Teboul JL. My patient has received fluid. How to assess its efficacy and side effects? Ann Intensive Care. 2018 Apr 24;8(1):54. doi: 10.1186/s13613-018-0400-z.
- Background: PubMed 35633423Monnet X, Shi R, Teboul JL. Prediction of fluid responsiveness. What's new? Ann Intensive Care. 2022 May 28;12(1):46. doi: 10.1186/s13613-022-01022-8.
- Background: PubMed 31097012Roger C, Zieleskiewicz L, Demattei C, Lakhal K, Piton G, Louart B, Constantin JM, Chabanne R, Faure JS, Mahjoub Y, Desmeulles I, Quintard H, Lefrant JY, Muller L; AzuRea Group. Time course of fluid responsiveness in sepsis: the fluid challenge revisiting (FCREV) study. Crit Care. 2019 May 16;23(1):179. doi: 10.1186/s13054-019-2448-z.
- Background: PubMed 31973735Kattan E, Ospina-Tascon GA, Teboul JL, Castro R, Cecconi M, Ferri G, Bakker J, Hernandez G; ANDROMEDA-SHOCK Investigators. Systematic assessment of fluid responsiveness during early septic shock resuscitation: secondary analysis of the ANDROMEDA-SHOCK trial. Crit Care. 2020 Jan 23;24(1):23. doi: 10.1186/s13054-020-2732-y.
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Sepsis
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.
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 Septic Shock and Fluid Responsiveness, 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 28 Nov 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 Rui SHI, M.D., Ph.D. (+33642170297, shiruidingding@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time delay from the state of fluid responsiveness to fluid unresponsiveness (time frame: 60 minutes after the evaluation of fluid responsiveness). The study lists 2 primary outcomes in all. 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 NCT05627817, which also lists 5 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 28 Nov 2022.