Acute Kidney InjuryAIKIDDONCT07924137
Acute Kidney Injury and Intermittent Dialysis Dose
An observational study of Acute Kidney Injury and Renal Dialysis, run by Assistance Publique - Hôpitaux de Paris.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Renal Dialysis, Renal Replacement Therapy
- What is being tested?
- Intermittent hemodialysis (no study-assigned intervention)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- 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 first-line or following continuous kidney replacement therapy
- Consent signed by the patient or a relative at inclusion
Who cannot join
- 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
Show all 10Show fewer
- Moribund patient with an estimated life expectancy 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Acute Kidney Injury, Renal Dialysis, Renal Replacement Therapy, Critical Illness, Intensive Care (ICU)
- Being tested
- Intermittent hemodialysis (no study-assigned intervention)
- Keywords
- Intermittent hemodialysis, Dialysis dose, Kt/V, Urea reduction ratio, Solute removal index
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent hemodialysis (no study-assigned intervention)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Intermittent hemodialysis (no study-assigned intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kt: volume of blood totally cleared of urea during the session (L)
Quantitative value of each dialysis dose parameter, measured at each dialysis session
Measured: Up to 30 days
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
Measured: Up to 30 days
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
Measured: Up to 30 days
URR: urea reduction ratio, based on post-dialysis plasma urea
Quantitative value of each dialysis dose parameter, measured at each dialysis session
Measured: Up to 30 days
SRI: solute removal index, based on urea in the effluent
Quantitative value of each dialysis dose parameter, measured at each dialysis session
Measured: Up to 30 days
Secondary outcomes (18)
Death or dialysis dependence
Binary variable: death or dialysis dependence before Day 29 after inclusion.
Measured: Up to day 29
Renal recovery
Defined by a glomerular filtration rate ≥ 60 mL/min/1.73 m2 (KDIGO).
Measured: Up to day 29
CAM-ICU (Confusion Assessment Method for the ICU)
positive or negative for delirium
Measured: At inclusion
CAM-ICU (Confusion Assessment Method for the ICU)
positive or negative for delirium
Measured: At day 3
CAM-ICU (Confusion Assessment Method for the ICU)
positive or negative for delirium
Measured: At day 6
CAM-ICU (Confusion Assessment Method for the ICU)
positive or negative for delirium
Measured: At day 29
Glasgow Coma Scale
varying to 3 to 15, higher scores indicating better consciousness
Measured: At inclusion
Glasgow Coma Scale
varying to 3 to 15, higher scores indicating better consciousness
Measured: At day 3
Glasgow Coma Scale
varying to 3 to 15, higher scores indicating better consciousness
Measured: At day 6
Glasgow Coma Scale
varying to 3 to 15, higher scores indicating better consciousness
Measured: At day 29
RASS (Richmond Agitation-Sedation Scale)
-5 (unarousable) to +4 (combative), 0 meaning alert and calm.
Measured: At inclusion
RASS (Richmond Agitation-Sedation Scale)
-5 (unarousable) to +4 (combative), 0 meaning alert and calm.
Measured: At day 3
RASS (Richmond Agitation-Sedation Scale)
-5 (unarousable) to +4 (combative), 0 meaning alert and calm.
Measured: At day 6
RASS (Richmond Agitation-Sedation Scale)
-5 (unarousable) to +4 (combative), 0 meaning alert and calm.
Measured: At day 29
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.
Measured: Up to day 29
Ratio of prescribed to delivered dialysis dose
At each dialysis session
Measured: Up to day 29
Duration of invasive mechanical ventilation
During the ICU stay
Measured: Up to day 29
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.
Measured: Up to day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924137
- Sponsor's protocol ID
- APHP260993
- Acronym
- AIKIDDO
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury and Intermittent Dialysis Dose
- ClinicalTrials.gov ID
- NCT07924137
- Acronym / sponsor ID
- AIKIDDO / APHP260993
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 9 Nov 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on intermittent hemodialysis | – | Other: Intermittent hemodialysis (no study-assigned intervention)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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 first-line or following continuous kidney replacement therapy
- Consent signed by the patient or a relative at inclusion
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Intermittent 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. | Other | Patients on intermittent hemodialysis |
Primary outcome
Kt: volume of blood totally cleared of urea during the session (L)
Time frame: Up to 30 days
Quantitative value of each dialysis dose parameter, measured at each dialysis session
Kt/Vd: Kt divided by the patient's urea distribution volume (Vd, L)
Time frame: Up to 30 days
Quantitative value of each dialysis dose parameter, measured at each dialysis session
Double-pool Kt/Vd: Kt/Vd calculated with a double-pool urea kinetic model
Time frame: Up to 30 days
Quantitative value of each dialysis dose parameter, measured at each dialysis session
URR: urea reduction ratio, based on post-dialysis plasma urea
Time frame: Up to 30 days
Quantitative value of each dialysis dose parameter, measured at each dialysis session
SRI: solute removal index, based on urea in the effluent
Time frame: Up to 30 days
Quantitative value of each dialysis dose parameter, measured at each dialysis session
18 secondary outcomes
Death or dialysis dependence
Time frame: Up to day 29
Renal recovery
Time frame: Up to day 29
CAM-ICU (Confusion Assessment Method for the ICU)
Time frame: At inclusion
CAM-ICU (Confusion Assessment Method for the ICU)
Time frame: At day 3
CAM-ICU (Confusion Assessment Method for the ICU)
Time frame: At day 6
CAM-ICU (Confusion Assessment Method for the ICU)
Time frame: At day 29
Glasgow Coma Scale
Time frame: At inclusion
Glasgow Coma Scale
Time frame: At day 3
Glasgow Coma Scale
Time frame: At day 6
Glasgow Coma Scale
Time frame: At day 29
RASS (Richmond Agitation-Sedation Scale)
Time frame: At inclusion
RASS (Richmond Agitation-Sedation Scale)
Time frame: At day 3
RASS (Richmond Agitation-Sedation Scale)
Time frame: At day 6
RASS (Richmond Agitation-Sedation Scale)
Time frame: At day 29
Hemodynamic instability
Time frame: Up to day 29
Ratio of prescribed to delivered dialysis dose
Time frame: Up to day 29
Duration of invasive mechanical ventilation
Time frame: Up to day 29
Time to death or dialysis dependence
Time frame: Up to day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Renal Dialysis, run by Assistance Publique - Hôpitaux de Paris.
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 5 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: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lara Zafrani (01 42 49 94 24 ext. +33, lara.zafrani@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kt: volume of blood totally cleared of urea during the session (L) (time frame: Up to 30 days). The study lists 5 primary outcomes in all. 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 9 Nov 2026.