Acute Kidney InjuryAARRTNCT06835816
Amino Acid Supplementation in Continuous Renal Replacement Therapy
A study testing Amino acid supplementation (Glavamin, Fresenius Kabi) in people with Acute Kidney Injury, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
ICU patients treated with continuous renal replacement therapy is recruited prior to start of treatment. Blood samples are drawn and then dialysis start without amino acid supplementation. After a few hours samples are drawn from blood and dialysate. 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?
- Amino acid supplementation (Glavamin, Fresenius Kabi)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 3 Feb 2025to 31 Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Dialysis where amino acid supplementation is planned by treating physician
Who cannot join
- Liver failure
- Muscle disease
- Neurodegenerative disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 14186
Jonathan Grip, MD,Phd, +46736230906, jonathan.grip@regionstockholm.se
Kristina Kilsand, R-Nurse, kristina.kilsand@regionstockholm.se
About this study
ICU patients treated with continuous renal replacement therapy is recruited prior to start of treatment.
Blood samples are drawn and then dialysis start without amino acid supplementation. After a few hours samples are drawn from blood and dialysate. Then patients are given amino acid supplementation (33.5g/24hrs) for 20-24 hours. New samples are drawn and amino acid supplementation is increased to 67g/24hrs and new samples are drawn after additional 24 hours. Then CRRT will continue with the full amino acid supplementation (standars of care).
- Conditions
- Acute Kidney Injury
- Being tested
- Amino acid supplementation (Glavamin, Fresenius Kabi)
- 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.
Amino acid supplementation (Glavamin, Fresenius Kabi)Dietary supplement
Mixture of amino acids (67 g / 500 ml) given intravenously
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All patients will start CRRT treatment without amino acid supplementation After a few hours samples are drawn from blood and dialysate Patients then receive low dose of supplementation for 24 hours (33.5g, 250 ml Glavamin, Fresenius Kabi) and new samples are drawn After that patients receive full supplementation (67g, 500 ml Glavamin, Fresenius Kabi) for the rest the of CRRT treatment. After 24 hours of this treatment new samples are drawn. Receives: Dietary Supplement: Amino acid supplementation (Glavamin, Fresenius Kabi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance of amino acids
Total balance of amino acid losses and supplementation given
Measured: After 3 days of dialysis
Secondary outcomes (2)
Amino acid concentration in plasma
Concentration of various amino acids in plasma without and with supplementation
Measured: After 3 days of dialysis
Concentration of vitamins and trace elements
Analysis of various trace elements and vitamins
Measured: After 3 days of dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start3 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT06835816
- Sponsor's protocol ID
- 2023-07570-01
- Other IDs
- 2023
- Acronym
- AARRT
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be availible per request
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acid Supplementation in Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT06835816
- Acronym / sponsor ID
- AARRT / 2023-07570-01
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Feb 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 treated with continuous renal replacement therapy is recruited prior to start of treatment.
Blood samples are drawn and then dialysis start without amino acid supplementation. After a few hours samples are drawn from blood and dialysate. Then patients are given amino acid supplementation (33.5g/24hrs) for 20-24 hours. New samples are drawn and amino acid supplementation is increased to 67g/24hrs and new samples are drawn after additional 24 hours. Then CRRT will continue with the full amino acid supplementation (standars of care).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Dietary Supplement: Amino acid supplementation (Glavamin, Fresenius Kabi)All patients will start CRRT treatment without amino acid supplementation After a few hours samples are drawn from blood and dialysate Patients then receive low dose of supplementation for 24 hours (33.5g, 250 ml Glavamin, Fresenius Kabi) and new samples are drawn After that patients receive full supplementation (67g, 500 ml Glavamin, Fresenius Kabi) for the rest the of CRRT treatment. After 24 hours of this treatment new samples are drawn. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dialysis where amino acid supplementation is planned by treating physician
Key exclusion criteria (3 listed)
- Liver failure
- Muscle disease
- Neurodegenerative disease
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 |
|---|---|---|
| Amino acid supplementation (Glavamin, Fresenius Kabi)Mixture of amino acids (67 g / 500 ml) given intravenously | Dietary supplement | All patients |
Primary outcome
Balance of amino acids
Time frame: After 3 days of dialysis
Total balance of amino acid losses and supplementation given
2 secondary outcomes
Amino acid concentration in plasma
Time frame: After 3 days of dialysis
Concentration of vitamins and trace elements
Time frame: After 3 days of dialysis
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 19 Feb 2025.
- Individual participant dataSharing planned: Undecided. Data will be availible per request
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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.
Jonathan Grip, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino acid supplementation (Glavamin, Fresenius Kabi) in people with Acute Kidney Injury, run by Karolinska University Hospital at 1 site in Sweden.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Feb 2025. 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 Sweden. 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?
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 (+46736230906, jonathan.grip@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance of amino acids (time frame: After 3 days of dialysis). 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 19 Feb 2025.