Acute Kidney InjuryUF CHALLENGENCT05214729

A Net Ultrafiltration Challenge to Predict Preload-dependence (UF CHALLENGE)

A study testing Fast ultrafiltration challenge and Slow ultrafiltration challenge in people with Acute Kidney Injury, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Kidney Injury
What is being tested?: Fast ultrafiltration challenge and Slow ultrafiltration challenge
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteFrance
Study dates: 14 Jul 2022to 2 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

adult patient, aged 18 year or older
under mechanical ventilation and continuous general anesthesia, with a positive end-expiratory pressure of 5 cmH2O or more
with stage 3 KDIGO acute kidney injury
treated with continuous renal replacement therapy for less than 14 days
ongoing continuous cardiac output monitoring
with a predicted intensive care length of stay of 24 hours or more at time of screening

Who cannot join

High arterial lactate concentration, > 4.0 mmol/L at time of screening
Calibrated cardiac index < 2.0 L/min/m2 or > 4.0 L/min/m2 at time of screening
Positive postural change maneuver in the last 2 hours preceding screening
Patient under extracorporeal membrane oxygenation
Patient with active bleeding requiring emergent transfusion
Patient under chronic maintenance dialysis or renal transplant recipient

Show all 14Show fewer

Acute ischemic or hemorrhagic stroke complicated with coma and requiring mechanical ventilation
Fulminant hepatitis (acute liver injury, hepatic encephalopathy, icterus and a drop in prothrombin < 50% in less that 15 days
Impossible postural change maneuver
Pregnant or lactating patient
Imminent death
Patient under legal protection measures as by French regulation
Patient already enrolled in the present study
Patient already participates in a study with protocolized net ultrafiltration, ongoing at time of screening

Trial locations and contacts

1 site in 1 country.

France1 site

Department of Intensive Care, Croix Rousse hospital, Hospices Civils de Lyon
Lyon, 69004

Other trials in France

About this study

Official title: Diagnostic Performance of a Net Ultrafiltration Challenge to Predict Preload Dependence in Critically Ill Patients Under Continuous Renal Replacement Therapy

Hemodynamic instability episodes are a frequent complication of renal replacement therapies in critically ill patients, and their incidence is associated with worse survival. Hypovolemia, identified by the existence of biventricular preload dependence, is responsible for one episode out of two, and may justify a decrease in or cessation of fluid removal by net ultrafiltration (UF). To date, preload dependence is most frequently identified by evaluating the effects on cardiac output of postural changes (passive leg raising), impact of cardio-pulmonary interactions in ventilated patients, or fluid challenge. However, none of these tests may help identify a patient whose cardiac output is at risk of becoming preload dependent, that is situated at the inflexion point of the Frank Starling curve.

Our study aims to evaluate the effects on cardiac output (measured by a transpulmonary thermodilution technique) of 2 net ultrafiltration challenges, consisting fast removal of 250 ml of ultrafiltrate over 15 and 30 minutes respectively, and compare their diagnostic performance to the reference technique of preload dependence assessed by postural changes (passive leg raising) performed after the UF challenge.

Enrolled participants will undergo both UF challenges, following a randomized crossover design, in which the order of UF challenge duration (15 or 30 minutes) is randomized, separated by a washout period of 24 hours.

Conditions: Acute Kidney Injury
Being tested: Fast ultrafiltration challenge, Slow ultrafiltration challenge
Keywords: acute kidney injury, renal replacement therapy, hemodynamics, preload dependence, net ultrafiltration
Medical subject headings: Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fast ultrafiltration challengeDiagnostic test
The fast ultrafiltration challenge will be performed once in all enrolled participants, in the order defined by randomization. The fast ultrafiltration challenge consists of the net removal of 250 ml of ultrafiltrate by setting net ultrafiltration rate to 1000 ml/h, applied for 15 minutes. The cardiac output will be measured before and after the UF challenge, by mean of the transpulmonary thermodilution technique, and its relative variation from baseline will be quantified to evaluate the impact of the UF challenge on cardiac preload.
The UF challenge will be preceded and immediately followed by a postural change maneuver to assess the presence or absence of preload dependence. The postural change maneuver is positive in case of a +10% variation in continuous cardiac index over 1 minute, and is considered as the reference diagnostic test to which UF challenge diagnostic performance will be compared.
Slow ultrafiltration challengeDiagnostic test
The slow ultrafiltration challenge will be performed once in all enrolled participants, in the order defined by randomization. The slow ultrafiltration challenge consists of the net removal of 250 ml of ultrafiltrate by setting net ultrafiltration rate to 500 ml/h, applied for 30 minutes. The cardiac output will be measured before and after the UF challenge, by mean of the transpulmonary thermodilution technique, and its relative variation from baseline will be quantified to evaluate the impact of the UF challenge on cardiac preload.
The UF challenge will be preceded and immediately followed by a postural change maneuver to assess the presence or absence of preload dependence. The postural change maneuver is positive in case of a +10% variation in continuous cardiac index over 1 minute, and is considered as the reference diagnostic test to which UF challenge diagnostic performance will be compared.

Study groups in NCT05214729
Study group	Role	What they receive
Fast to Slow Group	Experimental	The Fast to Slow Group corresponds to enrolled patients randomized, following the sequential crossover design, to first perform the fast UF challenge immediately after inclusion, followed by the slow UF challenge after a washout period of 24 hours. Receives: Diagnostic Test: Fast ultrafiltration challenge; Diagnostic Test: Slow ultrafiltration challenge
Slow to Fast Group	Experimental	The Slow to Fast Group corresponds to enrolled patients randomized, following the sequential crossover design, to first perform the slow UF challenge immediately after inclusion, followed by the fast UF challenge after a washout period of 24 hours. Receives: Diagnostic Test: Fast ultrafiltration challenge; Diagnostic Test: Slow ultrafiltration challenge

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic Performance of the Net Ultrafiltration (UF NET) Challenge to Detect de Novo Preload Dependence
The diagnostic performance was assessed using the area under the receiver-operating curve (AUROC) of the relative variation in calibrated cardiac index, measured at baseline and at the end of the challenge, and compared to the reference standard consisting in the result of a postural maneuver (passive leg raising or Trendelenburg) evaluating preload dependence using pulse-contour continuous cardiac index variation (positive if > 10% or negative if ≤ 10%) performed at the end of the challenge.
Measured: Baseline and immediately at the end ot each UF NET challenge (approximately 15-30 minutes, 1 day apart)

Secondary outcomes (2)

Respective Diagnostic Performance of the Fast and Slow Net Ultrafiltration (UF NET) Challenge to Detect de Novo Preload Dependence
The respective diagnostic performance of fast and slow challenges was assessed using the area under the receiver-operating curve (AUROC) of the relative variation in calibrated cardiac index, measured at baseline and at the end of fast and slow challenges, and compared to the reference standard consisting in the result of a postural maneuver (passive leg raising or Trendelenburg) evaluating preload dependence using pulse-contour continuous cardiac index variation (positive if > 10% or negative if ≤ 10%) performed at the end of the challenge.
Measured: Between baseline and end of the UF NET challenge
Preload Dependence Prevalence After a UF NET Challenge
The rate (in %) of UF NET challenges after which a preload-dependence status was identified using the reference diagnostic method, consisting of a postural maneuver (passive leg raising or Trendelenburg maneuver) during which the relative variation in pulse-contour continuous cardiac index was assessed over 1 minute. The test was positive if the relative variation in pulse-contour continuous cardiac index increased by more than 10% during the maneuver, and negative otherwise.
Measured: At the end of the UF NET challenge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 20222 Jan 2025

First posted31 Jan 2022
Study start14 Jul 2022
Primary completion2 Jan 2025
Study completion2 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Kidney InjuryStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05214729
Sponsor's protocol ID: 69HCL21_1250
Other IDs: 2021-A02939-32
Acronym: UF CHALLENGE
Status last verified: Jan 2026
First submitted: 17 Jan 2022
Last updated: 13 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Biscarrat C, Deniel G, Chivot M, Yonis H, Chauvelot L, Mezidi M, Richard JC, Bitker L. Diagnostic performance of a 250-ml net ultrafiltration challenge to identify risk of preload-dependence in critically ill patients undergoing continuous renal replacement therapy: a randomized, cross-over trial. Crit Care. 2025 Oct 21;29(1):446. doi: 10.1186/s13054-025-05674-3.
PubMed 41121412

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diagnostic Performance of a Net Ultrafiltration Challenge to Predict Preload Dependence in Critically Ill Patients Under Continuous Renal Replacement Therapy
ClinicalTrials.gov ID: NCT05214729
Acronym / sponsor ID: UF CHALLENGE / 69HCL21_1250
Conditions: Acute Kidney Injury
Keywords: acute kidney injury, renal replacement therapy, hemodynamics, preload dependence, net ultrafiltration
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Hospices Civils de LyonUniversity, hospital or other
Study start: 14 Jul 2022 (actual)
Primary completion: 2 Jan 2025 (actual)
Study completion: 2 Jan 2025 (actual)
First posted: 31 Jan 2022 (actual)
Results: Posted 13 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fast to Slow Group	Experimental	Diagnostic Test: Fast ultrafiltration challenge, Diagnostic Test: Slow ultrafiltration challengeThe Fast to Slow Group corresponds to enrolled patients randomized, following the sequential crossover design, to first perform the fast UF challenge immediately after inclusion, followed by the slow UF challenge after a washout period of 24 hours.
Slow to Fast Group	Experimental	Diagnostic Test: Fast ultrafiltration challenge, Diagnostic Test: Slow ultrafiltration challengeThe Slow to Fast Group corresponds to enrolled patients randomized, following the sequential crossover design, to first perform the slow UF challenge immediately after inclusion, followed by the fast UF challenge after a washout period of 24 hours.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

adult patient, aged 18 year or older
under mechanical ventilation and continuous general anesthesia, with a positive end-expiratory pressure of 5 cmH2O or more
with stage 3 KDIGO acute kidney injury
treated with continuous renal replacement therapy for less than 14 days
ongoing continuous cardiac output monitoring

Key exclusion criteria (14 listed)

High arterial lactate concentration, > 4.0 mmol/L at time of screening
Calibrated cardiac index < 2.0 L/min/m2 or > 4.0 L/min/m2 at time of screening
Positive postural change maneuver in the last 2 hours preceding screening
Patient under extracorporeal membrane oxygenation
Patient with active bleeding requiring emergent transfusion

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
Fast ultrafiltration challengeThe fast ultrafiltration challenge will be performed once in all enrolled participants, in the order defined by randomization. The fast ultrafiltration challenge consists of the net removal of 250 ml of ultrafiltrate by setting net ultrafiltration rate to 1000 ml/h, applied for 15 minutes. The cardiac output will be measured before and after the UF challenge, by mean of the transpulmonary thermodilution technique, and its relative variation from baseline will be quantified to evaluate the impact of the UF challenge on cardiac preload. The UF challenge will be preceded and immediately followed by a postural change maneuver to assess the presence or absence of preload dependence. The postural change maneuver is positive in case of a +10% variation in continuous cardiac index over 1 minute, and is considered as the reference diagnostic test to which UF challenge diagnostic performance will be compared.	Diagnostic test	Fast to Slow Group, Slow to Fast Group
Slow ultrafiltration challengeThe slow ultrafiltration challenge will be performed once in all enrolled participants, in the order defined by randomization. The slow ultrafiltration challenge consists of the net removal of 250 ml of ultrafiltrate by setting net ultrafiltration rate to 500 ml/h, applied for 30 minutes. The cardiac output will be measured before and after the UF challenge, by mean of the transpulmonary thermodilution technique, and its relative variation from baseline will be quantified to evaluate the impact of the UF challenge on cardiac preload. The UF challenge will be preceded and immediately followed by a postural change maneuver to assess the presence or absence of preload dependence. The postural change maneuver is positive in case of a +10% variation in continuous cardiac index over 1 minute, and is considered as the reference diagnostic test to which UF challenge diagnostic performance will be compared.	Diagnostic test	Fast to Slow Group, Slow to Fast Group

Primary outcome

Diagnostic Performance of the Net Ultrafiltration (UF NET) Challenge to Detect de Novo Preload Dependence
Time frame: Baseline and immediately at the end ot each UF NET challenge (approximately 15-30 minutes, 1 day apart)
The diagnostic performance was assessed using the area under the receiver-operating curve (AUROC) of the relative variation in calibrated cardiac index, measured at baseline and at the end of the challenge, and compared to the reference standard consisting in the result of a postural maneuver (passive leg raising or Trendelenburg) evaluating preload dependence using pulse-contour continuous cardiac index variation (positive if > 10% or negative if ≤ 10%) performed at the end of the challenge.

2 secondary outcomes

Respective Diagnostic Performance of the Fast and Slow Net Ultrafiltration (UF NET) Challenge to Detect de Novo Preload Dependence
Time frame: Between baseline and end of the UF NET challenge
Preload Dependence Prevalence After a UF NET Challenge
Time frame: At the end of the UF NET challenge

Results and safety

Results posted to the registry on 13 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Slow to Fast Group	10	10
Fast to Slow Group	10	10

Primary outcome: Diagnostic Performance of the Net Ultrafiltration (UF NET) Challenge to Detect de Novo Preload Dependence

Time frame: Baseline and immediately at the end ot each UF NET challenge (approximately 15-30 minutes, 1 day apart). Mean (95% Confidence Interval). Unit: Proportion probability (0 to 1)

Measure	All UF NET Challenges n = 20
Value	0.74 (0.58 to 0.88)

All UF NET Challenges: AUROC: 0.74 (95% CI 0.58 to 0.88), p = 0.02, Delong's test

Population analysed: All enrolled patients underwent two UF NET challenges, one fast and one slow, consisting in the removal of 250 ml of ultrafiltrate in randomized order and in a cross-over design (with a 24h wash-out period between challenged). 4 patients did not perform the second challenge due to the presence of predefined exit criteria during the wash-out period, as defined by the allocations sequence.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up (8h after the end of the second challenge, that is within a maximum time range of 56 hours avec enrollment). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fast UF NET Challenge	11 of 19 (57.9%)	0 of 19 (0%)	0 of 10
Slow UF NET Challenge	13 of 17 (76.5%)	0 of 17 (0%)	0 of 10

Limitations and caveats (from the sponsor): * Studied population: patients at high HIRRT risk, being under CRRT, mechanical ventilation and frequently receiving vasopressors, and all equipped with a CCI monitoring device. * 5 patients were a posteriori identified as being preload-dependent after inclusion. * Respective numbers of slow and fast challenges may have been insufficient to detect statistical differences when comparing challenge types * Trial design did not include a parallel arm in which a UFNET challenge was not performed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41121412Biscarrat C, Deniel G, Chivot M, Yonis H, Chauvelot L, Mezidi M, Richard JC, Bitker L. Diagnostic performance of a 250-ml net ultrafiltration challenge to identify risk of preload-dependence in critically ill patients undergoing continuous renal replacement therapy: a randomized, cross-over trial. Crit Care. 2025 Oct 21;29(1):446. doi: 10.1186/s13054-025-05674-3.

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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.

Laurent BITKER, MD principal investigator

Hospices Civils de Lyon

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fast ultrafiltration challenge and Slow ultrafiltration challenge in people with 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 6 inclusion and 14 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 13 Feb 2026. 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?

Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Diagnostic Performance of the Net Ultrafiltration (UF NET) Challenge to Detect de Novo Preload Dependence (time frame: Baseline and immediately at the end ot each UF NET challenge (approximately 15-30 minutes, 1 day apart)). 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 NCT05214729, which also lists 1 linked publication.

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 13 Feb 2026.