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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04755491

Registration number

NCT04755491

Ethics application status

Date submitted

11/02/2021

Date registered

16/02/2021

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

69HCL20_1055

Universal Trial Number (UTN)

Trial acronym

CLODICUS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute Kidney Injury

Condition category

Condition code

Renal and Urogenital

Kidney disease

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Treatment: Devices - Continuous veno-venous hemofiltration
Treatment: Devices - Continuous veno-venous hemodialysis
Treatment: Devices - Continuous veno-venous hemodiafiltration

Chloride transfer by continuous veno-venous hemofiltration - Chloride 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.

Chloride transfer by continuous veno-venous hemodialysis - Chloride 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.

Chloride transfer by continuous veno-venous hemodiafiltration - Chloride 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.

Treatment: Devices: Continuous veno-venous hemofiltration
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.

Treatment: Devices: Continuous veno-venous hemodialysis
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.

Treatment: Devices: Continuous veno-venous hemodiafiltration
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.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

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

Timepoint [1]

24 hours after inclusion

Eligibility

Key inclusion criteria

* 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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* 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
* Patients under guardianship or another juridical protection
* Patient's or next of kin opposition to participate
* Patients previously included in the study

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

16/03/2021

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

24/08/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

France

State/province [1]

Lyon

Funding & Sponsors

Primary sponsor type

Other

Name

Hospices Civils de Lyon

Address

Country

Ethics approval

Ethics application status

Summary

Brief 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. 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.

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.

Trial website

https://clinicaltrials.gov/study/NCT04755491

Trial related presentations / publications

Public notes

 This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts

Principal investigator

Name

Laurent BITKER, MD, PhD

Address

Hospices Civils de Lyon

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04755491

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04755491