Fluid RemovalNCT06425289
Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy
An observational study of Fluid Removal and Critically Ill, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy. A monocentric ancillary study of the EarlyDry randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Removal, Critically Ill, Continuous Renal Replacement Therapy
- What is being tested?
- Macrohemodynamic parameters
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2024to 1 Feb 2026
- 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: Critically ill patients with fluid overload and renal replacement therapy for fluid overload, included in EarlyDry trial (NCT05817539) and monitored with transpulmonary thermodilution.
Who may be able to join
- Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,
- At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or vasopressors administration>12 hours),
- Cumulative UF net less than 1000ml before inclusion,
- Norepinephrine < 0,5 µg/kg/min,
- Absence of hypoperfusion signs,
- Fluid overload defined as follows: fluid overload > 5% of base weight (based on cumulative fluid balance or a weight gain) and/or peripheral edema (AKIKI edema scale > 2).
Who cannot join
- Chronic renal failure hemodialyzed before admission to the ICU,
- Mechanical circulatory support (ECMO, LVAD),
- Pregnant, child -bearing age or lactating women,
- Stroke less than 30 days,
- Intestinal ischemia less than 7 days documented non-operated,
- Interventional study participation or exclusion period on going,
Show all 10Show fewer
- Guardianship, curatorship or safeguard of justice,
- Absence of signature of free and informed consent by the patient and/or relative,
- Patients not affiliated to a social security scheme or beneficiaries of a similar scheme
- Absence of transpulmonary thermodilution monitoring
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'anesthésie-réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
Bron, 69500
RUSTE MARTIN, Dr
About this study
Official title: Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy: A Monocentric Ancillary Study of the EarlyDry Randomized Controlled Trial
Macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy. A monocentric ancillary study of the EarlyDry randomized controlled trial.
- Being tested
- Macrohemodynamic parameters
- Keywords
- Fluid removal, Hemodynamic, Net ultrafiltration, Continuous renal replacement therapy
- Medical subject headings
- Critical Illness, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macrohemodynamic parametersOther
Macrohemodynamic parameters will be estimated with transpulmonary thermodilution every 6 hours during the intervention period (5 days).
- Cardiac index
- Extravascular lung water index
- Pulmonary vascular permeability index
- Cardiac function index
- Global end-diastolic volume index
- Central venous pressure
- Fluid responsivness status (passive leg rising test)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Corrective strategy | Procedure: Fluid balance negativation
During the RRT, UFnet will be settled on 2ml/kg/h and adapted to hemodynamic tolerance and tissue perfusion .
When the patient's baseline body weight is reached the UF net will be settled to maintain it.
In case of failure of the fluid balance negativation after 24h, UFnet will be settled on 3ml/kg/h. Then when the baseline body weight is reached UFnet will be settled on 0.5 et 1ml/kg/h or if necessary adapted to 1,5ml/kg/h to maintain it
In case of hemodynamic intolerance (NADN > 0,5 µg/kg/min) or tissue hypoperfusion, UF net will be stopped during 6 hours and restarted if NADN < 0,5 µg/kg/min and without tissue hypoperfusion. Receives: Other: Macrohemodynamic parameters | |
| Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled | Procedure: Body weight Stabilization
During the RRT, UFnet will be settled between 0 et 1 ml/kg/h and adapted in case of weight stabilization failure or hemodynamic intolerance.
In case of weight stabilisation failure (variation >5%), the UF net can be increased to 1,5 ml/kg/h.
In case of hemodynamic intolerance (NADN > 0,5 µg/kg/min), UF net will be stopped during 6 hours and restarted if NADN < 0,5 µg/kg/min. Receives: Other: Macrohemodynamic parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of a low cardiac index
Area under the curve of a cardiac index < 2.4 L/min/m2 (L/min/m2.hr), determined by transpulmonary thermodilution every 6 hours, with three boli of cold saline in the superior vena cava territory.
Measured: Every 6 hours between day 0 to day 5 (intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid RemovalStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
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
- NCT06425289
- Sponsor's protocol ID
- 69HCL23_5388
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 22 May 2024
- 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy: A Monocentric Ancillary Study of the EarlyDry Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06425289
- Acronym / sponsor ID
- 69HCL23_5388
- Keywords
- Fluid removal, Hemodynamic, Net ultrafiltration, Continuous renal replacement therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 22 May 2024 (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.
Macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy. A monocentric ancillary study of the EarlyDry randomized controlled trial.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Corrective strategy | – | Other: Macrohemodynamic parametersProcedure: Fluid balance negativation During the RRT, UFnet will be settled on 2ml/kg/h and adapted to hemodynamic tolerance and tissue perfusion . When the patient's baseline body weight is reached the UF net will be settled to maintain it. In case of failure of the fluid balance negativation after 24h, UFnet will be settled on 3ml/kg/h. Then when the baseline body weight is reached UFnet will be settled on 0.5 et 1ml/kg/h or if necessary adapted to 1,5ml/kg/h to maintain it In case of hemodynamic intolerance (NADN > 0,5 µg/kg/min) or tissue hypoperfusion, UF net will be stopped during 6 hours and restarted if NADN < 0,5 µg/kg/min and without tissue hypoperfusion. |
| Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled | – | Other: Macrohemodynamic parametersProcedure: Body weight Stabilization During the RRT, UFnet will be settled between 0 et 1 ml/kg/h and adapted in case of weight stabilization failure or hemodynamic intolerance. In case of weight stabilisation failure (variation >5%), the UF net can be increased to 1,5 ml/kg/h. In case of hemodynamic intolerance (NADN > 0,5 µg/kg/min), UF net will be stopped during 6 hours and restarted if NADN < 0,5 µg/kg/min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with fluid overload and renal replacement therapy for fluid overload, included in EarlyDry trial (NCT05817539) and monitored with transpulmonary thermodilution.
Key inclusion criteria (6 listed)
- Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,
- At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or vasopressors administration>12 hours),
- Cumulative UF net less than 1000ml before inclusion,
- Norepinephrine < 0,5 µg/kg/min,
- Absence of hypoperfusion signs,
Key exclusion criteria (10 listed)
- Chronic renal failure hemodialyzed before admission to the ICU,
- Mechanical circulatory support (ECMO, LVAD),
- Pregnant, child -bearing age or lactating women,
- Stroke less than 30 days,
- Intestinal ischemia less than 7 days documented non-operated,
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 |
|---|---|---|
| Macrohemodynamic parametersMacrohemodynamic parameters will be estimated with transpulmonary thermodilution every 6 hours during the intervention period (5 days). * Cardiac index * Extravascular lung water index * Pulmonary vascular permeability index * Cardiac function index * Global end-diastolic volume index * Central venous pressure * Fluid responsivness status (passive leg rising test) | Other | Experimental: Corrective strategy, Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled |
Primary outcome
Area under the curve of a low cardiac index
Time frame: Every 6 hours between day 0 to day 5 (intervention period)
Area under the curve of a cardiac index < 2.4 L/min/m2 (L/min/m2.hr), determined by transpulmonary thermodilution every 6 hours, with three boli of cold saline in the superior vena cava territory.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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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 Removal and Critically Ill, 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 6 inclusion and 10 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 22 May 2024. 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?
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?
Area under the curve of a low cardiac index (time frame: Every 6 hours between day 0 to day 5 (intervention period)). 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 22 May 2024.