Organ Failure, MultipleCAROTNCT04732481
Evaluation of Corrected Carotid Flow Time Variations During Passive Leg Lift to Predict Response to Filling.
An observational study of Organ Failure, Multiple, run by Centre Hospitalier de Cornouaille at 1 site in France.
Trial summary
Patients hospitalized in intensive care often require intravenous administration of fluid in order to optimize the functioning of the heart and thus ensure perfusion of vital organs such as the kidneys, the brain or the digestive tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Failure, Multiple
- What is being tested?
- passive leg lift test
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 1 Sep 2021
- 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: During their ICU admission for organ failure or multiple organ failure, patients frequently receive volume expansion to increase cardiac output.
Who may be able to join
- equipped with a PICCO2® continuous cardiac output monitoring device
- for which the practitioner in charge of the patient decides to administer a volume expansion
Who cannot join
- patients whose rhythm is non-sinus
- who have expressed their refusal to participate in the protocol
- contraindicated to passive leg lifting maneuvers (deep vein thrombosis, HTIC, BMI> 40 or> 14, spinal instability)
- pregnant women and patients clinically suspected of abdominal compartment syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Corrected Carotid Flow Time Variations During Passive Leg Lift to Predict Response to Filling
Patients hospitalized in intensive care often require intravenous administration of fluid in order to optimize the functioning of the heart and thus ensure perfusion of vital organs such as the kidneys, the brain or the digestive tract. However, it is necessary to find the right balance in fluid intake because it has been shown that excessive administration has a negative impact on patient survival, the length of their stay in intensive care or the duration of invasive mechanical ventilation.The passive leg lifting maneuver is regularly used to determine which patients should be infused with these large volumes (the patient's chest is placed in a horizontal position and the legs are elevated at 30 ° by tilting the bed for 2 minutes ). To be interpreted, this maneuver requires the presence of invasive devices (bloody arterial pressure catheter, PICCO monitor) or an operator experienced in cardiac ultrasound.Our study aims to evaluate an easy-to-use, non-invasive tool widely available in intensive care and emergency departments (carotid vascular doppler ultrasound) to assess the response to a passive leg lifting maneuver. . The measurements are taken before and after a passive leg lifting maneuver and then before and after a filling decided before inclusion by the doctor responsible for the patient.
- Conditions
- Organ Failure, Multiple
- Being tested
- passive leg lift test
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive leg lift testProcedure or surgery
passive leg lift test
| Study group | Role | What they receive |
|---|---|---|
| interventional group | passive leg lift test Receives: Procedure: passive leg lift test | |
| control group | no intervention (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
response to filling
Collection of the diagnosis of response to filling after volume expansion of 500mL of Isotonic Salted Serum and evaluation of the variation in TFCc during passive leg lifting between the two groups
Measured: 90sec
Secondary outcomes (1)
cut-off value for positivity of the test
The secondary objective of this work is to determine the best positivity threshold value of the test studied as well as its sensitivity and specificity for the chosen value.
Measured: 90sec
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Apr 2021
- Primary completion1 Jun 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ Failure, MultipleStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cornouaille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732481
- Sponsor's protocol ID
- QP-RIPH3-001
- Acronym
- CAROT
- Status last verified
- Mar 2022
- First submitted
- 27 Jan 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Corrected Carotid Flow Time Variations During Passive Leg Lift to Predict Response to Filling
- ClinicalTrials.gov ID
- NCT04732481
- Acronym / sponsor ID
- CAROT / QP-RIPH3-001
- Conditions
- Organ Failure, Multiple
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier de CornouailleUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 1 Feb 2021 (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.
Patients hospitalized in intensive care often require intravenous administration of fluid in order to optimize the functioning of the heart and thus ensure perfusion of vital organs such as the kidneys, the brain or the digestive tract. However, it is necessary to find the right balance in fluid intake because it has been shown that excessive administration has a negative impact on patient survival, the length of their stay in intensive care or the duration of invasive mechanical ventilation.The passive leg lifting maneuver is regularly used to determine which patients should be infused with these large volumes (the patient's chest is placed in a horizontal position and the legs are elevated at 30 ° by tilting the bed for 2 minutes ). To be interpreted, this maneuver requires the presence of invasive devices (bloody arterial pressure catheter, PICCO monitor) or an operator experienced in cardiac ultrasound.Our study aims to evaluate an easy-to-use, non-invasive tool widely available in intensive care and emergency departments (carotid vascular doppler ultrasound) to assess the response to a passive leg lifting maneuver. . The measurements are taken before and after a passive leg lifting maneuver and then before and after a filling decided before inclusion by the doctor responsible for the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | – | Procedure: passive leg lift testpassive leg lift test |
| control group | – | –no intervention (SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- During their ICU admission for organ failure or multiple organ failure, patients frequently receive volume expansion to increase cardiac output.
Key inclusion criteria (2 listed)
- equipped with a PICCO2® continuous cardiac output monitoring device
- for which the practitioner in charge of the patient decides to administer a volume expansion
Key exclusion criteria (4 listed)
- patients whose rhythm is non-sinus
- who have expressed their refusal to participate in the protocol
- contraindicated to passive leg lifting maneuvers (deep vein thrombosis, HTIC, BMI> 40 or> 14, spinal instability)
- pregnant women and patients clinically suspected of abdominal compartment syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| passive leg lift testpassive leg lift test | Procedure or surgery | interventional group |
Primary outcome
response to filling
Time frame: 90sec
Collection of the diagnosis of response to filling after volume expansion of 500mL of Isotonic Salted Serum and evaluation of the variation in TFCc during passive leg lifting between the two groups
1 secondary outcome
cut-off value for positivity of the test
Time frame: 90sec
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Organ Failure, Multiple, run by Centre Hospitalier de Cornouaille 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 4 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: finished, as of the sponsor's last update on 9 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response to filling (time frame: 90sec). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2022.