Acute Kidney InjuryIBRISTNCT06983197
Iatrogenic Deficiencies in ICU Patients With Prolonged Continuous Renal Replacement Therapy
An observational study of Acute Kidney Injury, run by Karolinska University Hospital.
Trial summary
ICU patients are recruited after at least 5 days treatment with continuous renal replacement therapy. Blood samples are drawn at time of recruitment and then every 3-5 days until ceseation of renal replacement therapy. Samples will be analyzed for concentrations of trace elements, vitamins and amino acids. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- blood test
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient of all ages treated with CRRT
Who may be able to join
- CRRT more than 5 days
- ICU care 10-15 days without any dialysis treatment
Who cannot join
- N/A
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
Official title: Iatrogena bristtillstånd Hos intensivvårdade Patienter Under långvarig Behandling Med Kontinuerlig Dialys
ICU patients are recruited after at least 5 days treatment with continuous renal replacement therapy. Blood samples are drawn at time of recruitment and then every 3-5 days until ceseation of renal replacement therapy.
Samples will be analyzed for concentrations of trace elements, vitamins and amino acids.
10 adult ICU patients treated for two weeks without renal replacement therapy will be sampled at one time point to serve as controls.
- Conditions
- Acute Kidney Injury
- Being tested
- blood test
- 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.
blood testDiagnostic test
Blood samples are drawn every 3-5 days in the RRT group but only once in the control group
| Study group | Role | What they receive |
|---|---|---|
| CRRT patients | Patients, all ages, that receive CRRT for at least five days. Receives: Diagnostic Test: blood test | |
| Non-CRRT patient | Adult patients, >17 yo, treated in the ICU for 10-15 days without renal replacement therapy Receives: Diagnostic Test: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of trace element
Measurments of trace elements and vitamins as compared to established reference values as well as non-CRRT controls
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (2)
Amino acids
Concentration of amino acids in plasma
Measured: From enrollment to the end of treatment at 4 weeks
Vitamins
Water soluble vitamins, concentration in plasma. Compared to non-crrt controls and established references
Measured: At all measuring points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (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 Karolinska University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Grip, Karolinska University Hospital
- Investigators
- Jonathan Grip, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983197
- Sponsor's protocol ID
- 2024-07642-01
- Acronym
- IBRIST
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be availible upon reasonable request but the small sample size number and specificity of medical conditions makes blinding to challenging for public release
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iatrogena bristtillstånd Hos intensivvårdade Patienter Under långvarig Behandling Med Kontinuerlig Dialys
- ClinicalTrials.gov ID
- NCT06983197
- Acronym / sponsor ID
- IBRIST / 2024-07642-01
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 May 2025 (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.
ICU patients are recruited after at least 5 days treatment with continuous renal replacement therapy. Blood samples are drawn at time of recruitment and then every 3-5 days until ceseation of renal replacement therapy.
Samples will be analyzed for concentrations of trace elements, vitamins and amino acids.
10 adult ICU patients treated for two weeks without renal replacement therapy will be sampled at one time point to serve as controls.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRRT patients | – | Diagnostic Test: blood testPatients, all ages, that receive CRRT for at least five days. |
| Non-CRRT patient | – | Diagnostic Test: blood testAdult patients, >17 yo, treated in the ICU for 10-15 days without renal replacement therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient of all ages treated with CRRT
Key inclusion criteria (2 listed)
- CRRT more than 5 days
- ICU care 10-15 days without any dialysis treatment
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| blood testBlood samples are drawn every 3-5 days in the RRT group but only once in the control group | Diagnostic test | CRRT patients, Non-CRRT patient |
Primary outcome
Concentration of trace element
Time frame: From enrollment to the end of treatment at 4 weeks
Measurments of trace elements and vitamins as compared to established reference values as well as non-CRRT controls
2 secondary outcomes
Amino acids
Time frame: From enrollment to the end of treatment at 4 weeks
Vitamins
Time frame: At all measuring points
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 21 May 2025.
- Individual participant dataSharing planned: No. Data will be availible upon reasonable request but the small sample size number and specificity of medical conditions makes blinding to challenging for public release
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Jonathan Grip, MD, PhD principal investigator
Karolinska University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Karolinska University Hospital.
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 2 inclusion and 1 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 21 May 2025. 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 Jonathan Grip, MD, PhD (+46 73 623 09 06, jonathan.grip@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of trace element (time frame: From enrollment to the end of treatment at 4 weeks). 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 21 May 2025.