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Acute Kidney InjuryCLODICUSNCT04755491

Chloride Transfer During Continuous Renal Replacement Therapy in the Intensive Care Unit: a Prospective Observational Cohort Study

An observational study of 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

Acute kidney injury (AKI) is a frequently encountered complication in the intensive care unit (ICU), affecting on average 25 to 35% of patients. It is associated with an increased mortality, proportional to AKI severity. RRT induces important shifts of water and electrolytes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury
What is being tested?
Continuous veno-venous hemofiltration, Continuous veno-venous hemodialysis and Continuous veno-venous hemodiafiltration
Type of treatment
Medical device
How many people
50 participants
Where
1 siteFrance
Study dates
16 Mar 2021to 24 Aug 2022
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: We will enroll all consecutive adult ICU patients, with stage III AKI (according to Kidney Disease: Improving Global Outcome (KDIGO) classification), and requiring continuous RRT (CVVH or CVVD or CVVHDF). Moreover, patients included will all be mechanically ventilated because of their initial clinical condition. This allows the selection of the most severe typology of ICU patients, in which the evaluation of chloride transfer may be the most relevant.

Who may be able to join

  • Adult patients (age > 18 years) affiliated to a social security regimen.
  • Presenting with stage III AKI according to Kidney Disease: Improving Global Outcome (KDIGO) classification28.
  • Treated with continuous RRT (CVVH or CVVD or CVVHDF) for less than 24 hours, whatever the method used.
  • Mechanically ventilated at the time of inclusion in the study.

Who cannot join

  • Patients on chronic hemodialysis / peritoneal dialysis.
  • Patients on extracorporeal membrane oxygenation
  • Patients on intermittent hemodialysis (acute or chronic)
  • RRT initiated for a different reason than stage III AKI according to Kidney Disease: Improving Global Outcome (KDIGO) classification
  • Withholding of life sustaining treatment concerning RRT, mechanical ventilation or cardiopulmonary resuscitation.
  • Patients whose life expectancy is lower than 24 hours
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  • Patients under guardianship or another juridical protection
  • Patient's or next of kin opposition to participate
  • Patients previously included in the study

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hôpital de la Croix-Rousse (Hospices Civils de Lyon) / Médecine Intensive - Réanimation

    Lyon, 69004

Other trials in France

About this study

Acute kidney injury (AKI) is a frequently encountered complication in the intensive care unit (ICU), affecting on average 25 to 35% of patients. It is associated with an increased mortality, proportional to AKI severity. RRT induces important shifts of water and electrolytes. Thus, significant amount of chloride might unintentionally be transferred to patients.

Chloride is the main anion of the organism. It is involved in the regulation of numerous physiological processes. Thus, significant and rapid modification of chloride amount contained in the organism (as might be induced by renal replacement therapy) may be responsible for important, and potentially deleterious, consequences to critically ill patients.

Read more

Studies have shown that the administration of high amounts of chloride rich solutions (such as sodium chloride (NaCl) 0,9%) was associated with the development of hyperchloremic acidosis in a dose-dependent manner. This hyperchloremic acidosis could also be theoretically associated with deleterious physiological effects. However, the true clinical consequences of administration of high amounts of chloride rich solutions remains unclear. Their effect on mortality remains a matter of debate, the results of studies being very conflicting in that respect. Nevertheless, hyperchloremia itself and/or the rise of chloremia in the intensive care unit seems to be associated with increased mortality. Moreover, the impact of those chloride rich solutions on the development of acute kidney injury is also a subject of controversy, data from the literature being here again very conflicting.

A recent study already showed that continuous RRT (CRRT) techniques induce a significant transfer of sodium to patients benefiting from those techniques. In that study, the amount of sodium transferred depended mainly on the difference between patient's natremia and sodium concentration in dialysate and/or replacement fluid (usually higher than patient's natremia) used.

By analogy, it is likely that an occult transfer of chloride also happens during RRT, given the high chloride concentration of dialysate fluids (in continuous veno-venous dialysis, CVVD) and replacement fluids (in continuous veno-venous hemofiltration, CVVH), or when these 2 modalities are combined (continuous veno-venous hemodiafiltration, CVVHDF). Finally, the investigators suspect, although it remains undemonstrated so far, that the RRT technique (convective vs. diffusive) may influence this transfer, to an unknown extent. Nevertheless, this transfer and its potential determinants have never been studied yet.

If chloride overload (and its potential clinical consequences) induced by the administration of solutions such as NaCl 0,9% is being extensively studied, no study has ever focused on chloride transfer that may result from the use of renal replacement therapy. However, as mentioned above, it is very likely that such a chloride transfer to patients happens, and that its magnitude depends on different parameters such as RRT modality, RRT fluids characteristics, or patient's chloremia at the start of RRT.

The investigators conduct the present study to describe and compare the intensity of chloride transfer during the first 24 hours of renal replacement therapy by continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVD),or continuous veno-venous hemodiafiltration (CVVHDF), and to determine if that transfer is more important with one or the other of those two techniques, in ICU patients affected with severe AKI requiring RRT. Secondary aims are to describe and compare the effects of chloride transfer under 3 RRT modalities (CVVD, CVVH and CVVHDF) on patient's outcome, organ failures, electrolyte and acid-base balance, fluid balance and hemodynamics. Finally, the investigators aim to develop a pharmacokinetic compartment model of chloride transfer during different modalities of RRT.

Being tested
Continuous veno-venous hemofiltration, Continuous veno-venous hemodialysis, Continuous veno-venous hemodiafiltration
Keywords
acute kidney injury, continuous renal replacement therapy, chloride transfer
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.

  • Continuous veno-venous hemofiltrationDevice

    Treatment of KDIGO stage 3 AKI by CVVH, in which renal replacement therapy is applied using a convection technique (ultrafiltration). Indication, choice of CRRT modality, and CRRT settings are made by the clinician in charge, following international recommendations. The measurement of chloride transfer over 24h is performed during CVVH treatment.

  • Continuous veno-venous hemodialysisDevice

    Treatment of KDIGO stage 3 AKI by CVVD, in which renal replacement therapy is applied using a diffusion technique (dialysis). Indication, choice of CRRT modality, and CRRT settings are made by the clinician in charge, following international recommendations. The measurement of chloride transfer over 24h is performed during CVVD treatment.

  • Continuous veno-venous hemodiafiltrationDevice

    Treatment of KDIGO stage 3 AKI by CVVHDF, in which renal replacement therapy is applied using a combination of diffusion technique (dialysis) and convection technique (ultrafiltration). Indication, choice of CRRT modality, and CRRT settings are made by the clinician in charge, following international recommendations. The measurement of chloride transfer over 24h is performed during CVVHDF treatment.

Study groups in NCT04755491
Study groupRoleWhat they receive
Chloride transfer by continuous veno-venous hemofiltrationChloride transfer over 24h of continuous veno-venous hemofiltration in mechanically ventilated ICU patients presenting with stage III AKI according to Kidney Disease: Improving Global Outcome (KDIGO) classification. Chloride concentrations will be measured in the serum, the urine, and the effluent of included patients every 4 to 6h from inclusion to H24.
Receives: Device: Continuous veno-venous hemofiltration
Chloride transfer by continuous veno-venous hemodialysisChloride transfer over 24h of continuous veno-venous hemodialysis in mechanically ventilated ICU patients presenting with stage III AKI according to Kidney Disease: Improving Global Outcome (KDIGO) classification. Chloride concentrations will be measured in the serum, the urine, and the effluent of included patients every 4 to 6h from inclusion to H24.
Receives: Device: Continuous veno-venous hemodialysis
Chloride transfer by continuous veno-venous hemodiafiltrationChloride transfer over 24h of continuous veno-venous hemodiafiltration in mechanically ventilated ICU patients presenting with stage III AKI according to Kidney Disease: Improving Global Outcome (KDIGO) classification. Chloride concentrations will be measured in the serum, the urine, and the effluent of included patients every 4 to 6h from inclusion to H24.
Receives: Device: Continuous veno-venous hemodiafiltration

What is being measured

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

  1. Amount of chloride (in mmol) transferred to the patient during the first 24 hours of RRT following inclusion

    The amount of chloride transferred is defined as the difference between chloride input administered via the RRT generator (dialysate and CaCl2 in CVVD, or replacement fluid in CVVH, or both in CVVHDF), and the chloride mass eliminated in the form of effluent (ultrafiltrate or spent dialysate), aggregated throughout the first 24 hours following inclusion.

    Measured: 24 hours after inclusion

Timeline

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

  1. First posted16 Feb 2021
  2. Study start16 Mar 2021
  3. Primary completion24 Aug 2022
  4. Study completion24 Aug 2022

Resources

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04755491
Sponsor's protocol ID
69HCL20_1055
Acronym
CLODICUS
Status last verified
Sep 2022
First submitted
11 Feb 2021
Last updated
13 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chivot M, Bellomo R, Deniel G, Richard JC, Bitker L. Chloride Mass Transfers during Continuous Veno-Venous Hemodialysis with Regional Citrate Anticoagulation: Effects of Additional Ultrafiltration and Hamburger's Effect. Blood Purif. 2025;54(7):404-412. doi: 10.1159/000546322. Epub 2025 May 28.

    PubMed 40435983

Questions about this trial

What is this clinical trial studying?

An observational study of 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 4 inclusion and 9 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 Sep 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?

Amount of chloride (in mmol) transferred to the patient during the first 24 hours of RRT following inclusion (time frame: 24 hours after inclusion). 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 NCT04755491, 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 Sep 2022.

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