ClinicalTrials.gg
Not yet recruitingNCT07924137AIKIDDOUpdated Nov 9, 2026

Acute Kidney Injury and Intermittent Dialysis Dose

An observational study in Acute Kidney Injury, Renal Dialysis and Renal Replacement Therapy, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

Intermittent hemodialysis (IHD) is the first-line kidney replacement modality in 50% of severe acute kidney injury (AKI) cases in French intensive care units (ICUs). It clears uremic toxins and restores acid-base and fluid-sodium balance, but the osmotic imbalance it induces can cause or worsen hemodynamic and neurological failure. Dialysis dose is a major prognostic issue, yet the optimal target and the best tools to quantify it in AKI remain debated.

Kt/Vd, validated in chronic kidney disease, is largely biased in AKI because the urea distribution volume is altered by fluid overload, capillary hyperpermeability and impaired tissue perfusion. Alternatives include the urea reduction ratio (URR) and the solute removal index (SRI), simple measures that each require only one additional sample, but their relevance for guiding IHD strategy remains to be demonstrated. Kt alone is considered reliable in AKI, as urea clearance measured by ionic dialysance has been validated in the ICU, but neither Kt nor Kt indexed to body weight or body surface area has been evaluated in clinical practice.

Current recommendations set a minimum dose of three 4-hour sessions per week, with a blood flow > 200 mL/min and a dialysate flow > 500 mL/min. This target standardizes care and simplifies planning, but the lack of personalization and of session quality measurement may lead to an inadequate dose in some patients.

AIKIDDO is an observational study of 200 adult ICU patients with KDIGO stage 3 AKI treated with IHD. It aims to assess the agreement between dialysis dose measures (Kt/Vd, double-pool Kt/Vd, Kt, URR, SRI) obtained at each dialysis session. Patients are followed until Day 29 for death, dialysis dependence, renal recovery, neurological status, hemodynamic instability during sessions and duration of invasive mechanical ventilation.

02

Conditions studied

  • Acute Kidney Injury
  • Renal Dialysis
  • Renal Replacement Therapy
  • Critical Illness
  • Intensive Care (ICU)

Keywords

  • Intermittent hemodialysis
  • Dialysis dose
  • Kt/V
  • Urea reduction ratio
  • Solute removal index
03

In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's planned enrollment of 200 is above the median of 160 across 814 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients admitted to an intensive care unit who develop, during their stay, stage 3 acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) classification, requiring intermittent kidney replacement therapy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patient (age > 18 years) admitted to the ICU
  • Affiliated with a social security scheme
  • KDIGO stage 3 acute kidney injury during the ICU stay
  • Treated with IHD, either or following continuous kidney replacement therapy
  • Consent signed by the patient or a relative at inclusion

Exclusion criteria

Exclusion Criteria:

  • Patient receiving chronic dialysis (hemodialysis, peritoneal dialysis)
  • Patient who has received two or more IHD sessions during the ICU stay
  • Kidney transplant recipient with a functioning graft
  • Ongoing veno-venous or veno-arterial ECMO (extracorporeal membrane oxygenation)
  • Kidney replacement therapy initiated for an indication other than KDIGO stage 3 acute kidney injury (e.g., drug poisoning)
  • Pregnant or breastfeeding patient
  • Moribund patient with an estimated of less than 24 hours
  • Patient under guardianship, curatorship or other legal protection
  • Patient covered by French State Medical Aid (AME)
  • Patient previously included in the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients on intermittent hemodialysis

    Adult ICU patients with KDIGO stage 3 AKI treated with IHD, either first-line or following continuous kidney replacement therapy. In these patients, the study assesses the agreement between different measures of dialysis dose (Kt/Vd, double-pool Kt/Vd, Kt, URR, SRI).

    Other: Intermittent hemodialysis (no study-assigned intervention)

Interventions

  • OtherIntermittent hemodialysis (no study-assigned intervention)

    No intervention is assigned by the study. Patients receive IHD as part of their ICU care, and dialysis dose measures (Kt/Vd, double-pool Kt/Vd, Kt, URR, SRI) are obtained at each dialysis session.

06

What researchers measure

Primary outcomes

  1. Kt: volume of blood totally cleared of urea during the session (L)

    Quantitative value of each dialysis dose parameter, measured at each dialysis session

    Time frame: Up to 30 days

  2. Kt/Vd: Kt divided by the patient's urea distribution volume (Vd, L)

    Quantitative value of each dialysis dose parameter, measured at each dialysis session

    Time frame: Up to 30 days

  3. Double-pool Kt/Vd: Kt/Vd calculated with a double-pool urea kinetic model

    Quantitative value of each dialysis dose parameter, measured at each dialysis session

    Time frame: Up to 30 days

  4. URR: urea reduction ratio, based on post-dialysis plasma urea

    Quantitative value of each dialysis dose parameter, measured at each dialysis session

    Time frame: Up to 30 days

  5. SRI: solute removal index, based on urea in the effluent

    Quantitative value of each dialysis dose parameter, measured at each dialysis session

    Time frame: Up to 30 days

Secondary outcomes

  1. Death or dialysis dependence

    Binary variable: death or dialysis dependence before Day 29 after inclusion.

    Time frame: Up to day 29

  2. Renal recovery

    Defined by a glomerular filtration rate ≥ 60 mL/min/1.73 m2 (KDIGO).

    Time frame: Up to day 29

  3. CAM-ICU (Confusion Assessment Method for the ICU)

    positive or negative for delirium

    Time frame: At inclusion

  4. CAM-ICU (Confusion Assessment Method for the ICU)

    positive or negative for delirium

    Time frame: At day 3

  5. CAM-ICU (Confusion Assessment Method for the ICU)

    positive or negative for delirium

    Time frame: At day 6

  6. CAM-ICU (Confusion Assessment Method for the ICU)

    positive or negative for delirium

    Time frame: At day 29

  7. Glasgow Coma Scale

    varying to 3 to 15, higher scores indicating better consciousness

    Time frame: At inclusion

  8. Glasgow Coma Scale

    varying to 3 to 15, higher scores indicating better consciousness

    Time frame: At day 3

  9. Glasgow Coma Scale

    varying to 3 to 15, higher scores indicating better consciousness

    Time frame: At day 6

  10. Glasgow Coma Scale

    varying to 3 to 15, higher scores indicating better consciousness

    Time frame: At day 29

  11. RASS (Richmond Agitation-Sedation Scale)

    -5 (unarousable) to +4 (combative), 0 meaning alert and calm.

    Time frame: At inclusion

  12. RASS (Richmond Agitation-Sedation Scale)

    -5 (unarousable) to +4 (combative), 0 meaning alert and calm.

    Time frame: At day 3

  13. RASS (Richmond Agitation-Sedation Scale)

    -5 (unarousable) to +4 (combative), 0 meaning alert and calm.

    Time frame: At day 6

  14. RASS (Richmond Agitation-Sedation Scale)

    -5 (unarousable) to +4 (combative), 0 meaning alert and calm.

    Time frame: At day 29

  15. Hemodynamic instability

    During IHD sessions Defined as vascular filling and/or initiation or increase of a vasopressor and/or discontinuation or reduction of the ultrafiltration rate.

    Time frame: Up to day 29

  16. Ratio of prescribed to delivered dialysis dose

    At each dialysis session

    Time frame: Up to day 29

  17. Duration of invasive mechanical ventilation

    During the ICU stay

    Time frame: Up to day 29

  18. Time to death or dialysis dependence

    Time from diagnosis of AKI requiring IHD to death, or to Day 29 for patients alive at 30 days. Events are death before Day 29 and dialysis dependence at Day 29.

    Time frame: Up to day 29

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07924137
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Nov 9, 2026

Study contacts

Lara Zafrani
Contact
lara.zafrani@aphp.fr
01 42 49 94 24 ext. +33
Jérôme Lambert
Contact
jerome.lambert@u-paris.fr
0142499742 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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