Fluid OverloadDeepCARTNCT06899880
Perfusion Parameters and Outcome During a Standardized Deresuscitation Strategy with Net Ultrafiltration: a Retrospective Cohort Study.
An observational study of Fluid Overload and Acute Kidney Injury, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Hemodynamic tolerance of fluid removal during deresuscitation is a cornerstone of the impact on outcome of such a strategy. However, how to define and to predict hemodynamic tolerance to fluid removal remains controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload, Acute Kidney Injury, Continuous Renal Replacement Therapy
- What is being tested?
- Describe the perfusion parameters during a deresuscitation strategy and their association with the outcome.
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 1 Apr 2024
- 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
- Adult, Older adult
Study population: adults' patients with fluid overload and continuous renal replacement therapy in intensive care unit
Who may be able to join
- Age ≥ 18 years old
- Acute kidney injury requiring continuous renal replacement therapy
- Standardized deresuscitation following a routine care protocol
Who cannot join
- Chronic hemodialysis
- Advanced directives to withhold or withdraw life-sustaining treatment,
- Patient's opposition to the use of his/her personal health data
Trial locations and contacts
1 site in 1 country.
About this study
Hemodynamic tolerance of fluid removal during deresuscitation is a cornerstone of the impact on outcome of such a strategy. However, how to define and to predict hemodynamic tolerance to fluid removal remains controversial. The investigators routinely use a standardized deresuscitation protocol in patients with fluid overload and continuous renal replacement therapy combined with monitoring of clinical and biological perfusion parameters.
The aim of the study was to describe perfusion during deresuscitation, and to determine whether it is associated with major adverse kidney events at day 30.
- Being tested
- Describe the perfusion parameters during a deresuscitation strategy and their association with the outcome.
- Medical subject headings
- Edema, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Describe the perfusion parameters during a deresuscitation strategy and their association with the outcome.Other
Arterial lactate, pCO2 gap, SvO2, capillary refill time and mottling score anomalies will be described during the first 5 days of the deresuscitation strategy.
| Study group | Role | What they receive |
|---|---|---|
| Standardized deresuscitation strategy | Eligible patients without hypoperfusion benefited from: 1) a restrictive approach of intakes combining hypercaloric enteral or per os feeding with hydric restriction as much as possible and no fluid of maintenance, and 2) a systematic UFnet of 2 mL/kg/h until reaching dry weight and a systematic monitoring every 6 h of: peripheral perfusion by capillary refilling time and mottling score, arterial lactate level, and central venous oxygen saturation. Receives: Other: Describe the perfusion parameters during a deresuscitation strategy and their association with the outcome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAKE 30
Major adverse kidney event at day 30, defined as follows:
- Death OR
- No weaning of renal replacement therapy OR
- Serum creatinine > 2 times baseline serum creatinine
Measured: A day 30 after the initiation of the deresuscitation strategy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Jan 2024
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899880
- Sponsor's protocol ID
- 24-5563
- Acronym
- DeepCART
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Parameters and Outcome During a Standardized Deresuscitation Strategy with Net Ultrafiltration: a Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT06899880
- Acronym / sponsor ID
- DeepCART / 24-5563
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 28 Mar 2025 (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.
Hemodynamic tolerance of fluid removal during deresuscitation is a cornerstone of the impact on outcome of such a strategy. However, how to define and to predict hemodynamic tolerance to fluid removal remains controversial. The investigators routinely use a standardized deresuscitation protocol in patients with fluid overload and continuous renal replacement therapy combined with monitoring of clinical and biological perfusion parameters.
The aim of the study was to describe perfusion during deresuscitation, and to determine whether it is associated with major adverse kidney events at day 30.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardized deresuscitation strategy | – | Other: Describe the perfusion parameters during a deresuscitation strategy and their association with the outcome.Eligible patients without hypoperfusion benefited from: 1) a restrictive approach of intakes combining hypercaloric enteral or per os feeding with hydric restriction as much as possible and no fluid of maintenance, and 2) a systematic UFnet of 2 mL/kg/h until reaching dry weight and a systematic monitoring every 6 h of: peripheral perfusion by capillary refilling time and mottling score, arterial lactate level, and central venous oxygen saturation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adults' patients with fluid overload and continuous renal replacement therapy in intensive care unit
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Acute kidney injury requiring continuous renal replacement therapy
- Standardized deresuscitation following a routine care protocol
Key exclusion criteria (3 listed)
- Chronic hemodialysis
- Advanced directives to withhold or withdraw life-sustaining treatment,
- Patient's opposition to the use of his/her personal health data
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 |
|---|---|---|
| Describe the perfusion parameters during a deresuscitation strategy and their association with the outcome.Arterial lactate, pCO2 gap, SvO2, capillary refill time and mottling score anomalies will be described during the first 5 days of the deresuscitation strategy. | Other | Standardized deresuscitation strategy |
Primary outcome
MAKE 30
Time frame: A day 30 after the initiation of the deresuscitation strategy
Major adverse kidney event at day 30, defined as follows: * Death OR * No weaning of renal replacement therapy OR * Serum creatinine > 2 times baseline serum creatinine
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 28 Mar 2025.
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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 Fluid Overload and Acute Kidney Injury, run by Hospices Civils de Lyon 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 3 inclusion and 3 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 28 Mar 2025. 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?
MAKE 30 (time frame: A day 30 after the initiation of the deresuscitation strategy). 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 28 Mar 2025.