Acute Kidney Injury (Nontraumatic)NCT07467889
Impact of CRRT on Serum Carnitine and Micronutrient Levels
An observational study of Acute Kidney Injury (Nontraumatic) and Critical Illness, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the changes in blood levels of micronutrients and carnitine in critically ill patients with Acute Kidney Injury (AKI) who are undergoing Continuous Renal Replacement Therapy (CRRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury (Nontraumatic), Critical Illness
- What is being tested?
- Continuous Renal Replacement Therapy (CRRT)
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 15 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population consists of adult patients (aged 18-90 years) admitted to a 36-bed general Intensive Care Unit (ICU) in a tertiary education and research hospital. The population focuses on patients diagnosed with Acute Kidney Injury (AKI) Stage 2 or 3 according to the KDIGO clinical practice guidelines. Participants are selected from patients who require an evaluation for Continuous Renal Replacement Therapy (CRRT) within the first hour of their ICU admission. The cohort includes a diverse range of critically ill patients, excluding those with end-stage chronic conditions or specific comorbidities that could confound the analysis of micronutrient clearance
Who may be able to join
- Patients aged 18-90 years
- Diagnosis of AKI Stage 2 or 3 according to KDIGO
- Evaluation for CRRT requirement within the first hour of ICU admission.
Who cannot join
- End-stage renal disease or history of chronic RRT
- AKI due to dialyzable toxins,Child-Pugh C liver cirrhosis
- Terminal malignancy,AKI secondary to cardiac arrest
- High risk of mortality within the first 24 hours
- Prior RRT for the current AKI episode,History of kidney transplantation
- Prior inclusion in this study
- Pregnancy or breastfeeding
- Lack of informed consent from the patient or legal representative.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital, Intensive Care Clinic
Ankara, keçiören, 06010
About this study
Official title: The Carnitine Dichotomy in CRRT: Dialytic Depletion of Short-Chain Fractions Versus Retention of Long-Chain Mitochondrial Biomarkers.
This study aims to investigate the changes in blood levels of micronutrients and carnitine in critically ill patients with Acute Kidney Injury (AKI) who are undergoing Continuous Renal Replacement Therapy (CRRT). While CRRT is a life-saving intervention for managing metabolic disturbances and fluid overload in patients with Stage 2-3 AKI, it may also lead to the inadvertent removal of essential micronutrients (vitamins, trace elements, and amino acids) through the extracorporeal circuit.
The research will prospectively compare 100 adult patients across two groups: those receiving CRRT and those managed without CRRT. Researchers will analyze blood samples and effluent fluid to determine the clearance rates and total losses of various substances, including carnitine, selenium, zinc, and various amino acids. By comparing levels at the first hour and 24th hour of intensive care admission, the study seeks to determine if CRRT significantly contributes to micronutrient deficiencies in this vulnerable population.
Read the detailed description
Background and Rationale:
Acute Kidney Injury (AKI) is characterized by a sudden loss of glomerular filtration rate and is a major factor increasing mortality and morbidity in hospitalized patients. In critically ill patients, Continuous Renal Replacement Therapy (CRRT) is frequently used to manage metabolic disturbances and fluid overload due to its advantages in hemodynamic stability. However, exposure to the extracorporeal circuit may lead to significant losses of micronutrients, including trace elements (e.g., selenium, zinc, copper) and water-soluble vitamins, which play crucial roles in cellular function and metabolism.
Study Objective:
The primary objective of this prospective study is to investigate the changes in serum and effluent (waste fluid) micronutrient levels in patients undergoing CRRT and to compare these levels with patients who have Stage 2-3 AKI but do not require CRRT.
Methodology and Procedures:
Study Setting and Design This prospective study was conducted in a 36-bed general Intensive Care Unit (ICU) at a tertiary education and research hospital. Patients diagnosed with Acute Kidney Injury (AKI) Stage 2 or 3 according to the KDIGO guidelines were included. Within the first hour of ICU admission, patients were evaluated for Continuous Renal Replacement Therapy (CRRT) requirement and divided into two groups: those receiving CRRT and those not receiving CRRT. The decision to initiate CRRT was made by the attending clinician independent of the study team.
Eligibility Criteria Inclusion criteria were:
Patients aged 18-90 years,Diagnosis of AKI Stage 2 or 3 according to KDIGO,Evaluation for CRRT requirement within the first hour of ICU admission.
Exclusion criteria included:End-stage renal disease or history of chronic RRT., AKI due to dialyzable toxins,Child-Pugh C liver cirrhosis,Terminal malignancy,AKI secondary to cardiac arrest,High risk of mortality within the first 24 hours,Prior RRT for the current AKI episode,History of kidney transplantation,Prior inclusion in this study,Pregnancy or breastfeeding,Lack of informed consent from the patient or legal representative.
Clinical Data and Sample Collection Demographic data (age, sex), APACHE-II and SOFA scores, BMI, and admission diagnoses were recorded. Routine laboratory parameters including serum albumin, total protein, creatinine, urea, electrolytes, CRP, and blood gas values (pH, bicarbonate, lactate) were measured at the 1st and 24th hours.For micronutrient analysis, blood samples were collected at the 1st hour of ICU admission for all patients. Subsequent sampling was performed at the 24th hour of CRRT for the treatment group and at the 24th hour of ICU stay for the non-CRRT group. Samples were centrifuged at 4000 rpm for 5 minutes and stored at -80°C. Analyzed parameters included:Trace elements: Selenium, zinc, copper, iron.Vitamins: Vitamin B12, Vitamin C, folate.Amino acids: 22 subforms including leucine, isoleucine, valine, and others.Carnitine: Various subforms.CRRT Procedure and Effluent Analysis All CRRT procedures were performed in Continuous Veno-venous Hemodialysis (CVVHD) mode at a dose of 30 mL/kg/hour. An Ultraflux AV1000S polysulfone filter (1.8 m2) was used. Anticoagulation was achieved with unfractionated heparin, and no ultrafiltration was applied during the study period. Dialysate flow rate (Qd) was maintained at 30% of the blood flow rate (Qb) to ensure ideal dialysate saturation, with Qb fixed between 100-140 mL/min.To calculate extracorporeal losses, 20 mL samples were collected from each effluent bag during the 24-hour CRRT period and stored at -80°C. Total loss was calculated by multiplying the concentration in each bag by its total volume. Due to instability under light and room temperature, vitamins (C and B12) were excluded from effluent analysis to avoid confounding results.
- Being tested
- Continuous Renal Replacement Therapy (CRRT), Standard of Care (Non-CRRT Management)
- Keywords
- Acute Kidney Injury, Critical Illness, Continuous Renal Replacement Therapy (CRRT), Effluent Analysis
- 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.
Continuous Renal Replacement Therapy (CRRT)Procedure or surgery
atients receive CRRT in Continuous Veno-venous Hemodialysis (CVVHD) mode with a target dose of 30 mL/kg/hour. The procedure uses a polysulfone Ultraflux AV1000S filter with a surface area of 1.8 m2. Anticoagulation is provided with unfractionated heparin. Blood flow rate (Qb) is set between 100-140 mL/min, and dialysate flow rate (Qd) is adjusted to 30% of Qb to ensure optimal saturation
Standard of Care (Non-CRRT Management)Other
Patients with Stage 2-3 AKI who do not meet the criteria for CRRT or are managed with conservative medical therapy according to the attending clinician's decision. These patients receive routine ICU care without extracorporeal treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracorporeal Clearance of Micronutrients and Carnitine
Calculation of the clearance rates for trace elements (selenium, zinc, copper, iron), carnitine subforms, and 22 different amino acids by analyzing their concentrations in the blood and effluent (waste fluid) during the 24-hour Continuous Renal Replacement Therapy (CRRT) period.
Measured: At the 24th hour of Continuous Renal Replacement Therapy (CRRT)
Secondary outcomes (5)
Changes in Serum Carnitine Concentrations
Comparison of serum levels of carnitine between the 1st hour of ICU admission and the 24th hour.
Measured: Baseline (1st hour of admission) and 24 hours
comparison of serum amino acid concentration
comparison of serum amino acid concentration between first hour of intensive care unite admission and the 24th hour
Measured: first hour of intensive care unite admission and the 24th hour
comparison of serum vitamins(B12,folat) concentrations
comparison of serum vitamins(B12,folat) concentration between first hour of intensive care admission and the 24 th hour
Measured: first hour of intensive care admission and the 24 th hour
The difference in micronutrient status between patients receiving and not receiving CRRT.
Comparison of serum micronutrient, vitamin, and amino acid concentrations between the group receiving Continuous Renal Replacement Therapy (CRRT) at a dose of 30 mL/kg/hour and the control group (non-CRRT ICU patients). This aims to isolate the effect of the CRRT filter on nutritional loss compared to standard ICU metabolic changes.
Measured: 24 hours after hospital admission/start of treatment.
Clinical Correlation
Assessment of the relationship between micronutrient losses and clinical severity scores (APACHE-II, SOFA) and inflammatory markers (CRP).
Measured: Through study completion (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Jan 2023
- Primary completion15 Mar 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Injury (Nontraumatic)Studies of the same condition, open and under way.
- 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mete Erdemir, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467889
- Sponsor's protocol ID
- 2022/24
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Fah M, Van Althuis LE, Ohnuma T, Winthrop HM, Haines KL, Williams DGA, Krishnamoorthy V, Raghunathan K, Wischmeyer PE. Micronutrient deficiencies in critically ill patients receiving continuous renal replacement therapy. Clin Nutr ESPEN. 2022 Aug;50:247-254. doi: 10.1016/j.clnesp.2022.05.008. Epub 2022 May 23.
PubMed 35871932Koekkoek KWA, Berger MM. An update on essential micronutrients in critical illness. Curr Opin Crit Care. 2023 Aug 1;29(4):315-329. doi: 10.1097/MCC.0000000000001062. Epub 2023 Jun 8.
PubMed 37306546Berger MM, Shenkin A, Schweinlin A, Amrein K, Augsburger M, Biesalski HK, Bischoff SC, Casaer MP, Gundogan K, Lepp HL, de Man AME, Muscogiuri G, Pietka M, Pironi L, Rezzi S, Cuerda C. ESPEN micronutrient guideline. Clin Nutr. 2022 Jun;41(6):1357-1424. doi: 10.1016/j.clnu.2022.02.015. Epub 2022 Feb 26.
PubMed 35365361
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Carnitine Dichotomy in CRRT: Dialytic Depletion of Short-Chain Fractions Versus Retention of Long-Chain Mitochondrial Biomarkers.
- ClinicalTrials.gov ID
- NCT07467889
- Acronym / sponsor ID
- 2022/24
- Keywords
- Acute Kidney Injury, Critical Illness, Continuous Renal Replacement Therapy (CRRT), Effluent Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 12 Mar 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.
This study aims to investigate the changes in blood levels of micronutrients and carnitine in critically ill patients with Acute Kidney Injury (AKI) who are undergoing Continuous Renal Replacement Therapy (CRRT). While CRRT is a life-saving intervention for managing metabolic disturbances and fluid overload in patients with Stage 2-3 AKI, it may also lead to the inadvertent removal of essential micronutrients (vitamins, trace elements, and amino acids) through the extracorporeal circuit.
The research will prospectively compare 100 adult patients across two groups: those receiving CRRT and those managed without CRRT. Researchers will analyze blood samples and effluent fluid to determine the clearance rates and total losses of various substances, including carnitine, selenium, zinc, and various amino acids. By comparing levels at the first hour and 24th hour of intensive care admission, the study seeks to determine if CRRT significantly contributes to micronutrient deficiencies in this vulnerable population.
Detailed description
Background and Rationale:
Acute Kidney Injury (AKI) is characterized by a sudden loss of glomerular filtration rate and is a major factor increasing mortality and morbidity in hospitalized patients. In critically ill patients, Continuous Renal Replacement Therapy (CRRT) is frequently used to manage metabolic disturbances and fluid overload due to its advantages in hemodynamic stability. However, exposure to the extracorporeal circuit may lead to significant losses of micronutrients, including trace elements (e.g., selenium, zinc, copper) and water-soluble vitamins, which play crucial roles in cellular function and metabolism.
Study Objective:
The primary objective of this prospective study is to investigate the changes in serum and effluent (waste fluid) micronutrient levels in patients undergoing CRRT and to compare these levels with patients who have Stage 2-3 AKI but do not require CRRT.
Methodology and Procedures:
Study Setting and Design This prospective study was conducted in a 36-bed general Intensive Care Unit (ICU) at a tertiary education and research hospital. Patients diagnosed with Acute Kidney Injury (AKI) Stage 2 or 3 according to the KDIGO guidelines were included. Within the first hour of ICU admission, patients were evaluated for Continuous Renal Replacement Therapy (CRRT) requirement and divided into two groups: those receiving CRRT and those not receiving CRRT. The decision to initiate CRRT was made by the attending clinician independent of the study team.
Eligibility Criteria Inclusion criteria were:
Patients aged 18-90 years,Diagnosis of AKI Stage 2 or 3 according to KDIGO,Evaluation for CRRT requirement within the first hour of ICU admission.
Exclusion criteria included:End-stage renal disease or history of chronic RRT., AKI due to dialyzable toxins,Child-Pugh C liver cirrhosis,Terminal malignancy,AKI secondary to cardiac arrest,High risk of mortality within the first 24 hours,Prior RRT for the current AKI episode,History of kidney transplantation,Prior inclusion in this study,Pregnancy or breastfeeding,Lack of informed consent from the patient or legal representative.
Clinical Data and Sample Collection Demographic data (age, sex), APACHE-II and SOFA scores, BMI, and admission diagnoses were recorded. Routine laboratory parameters including serum albumin, total protein, creatinine, urea, electrolytes, CRP, and blood gas values (pH, bicarbonate, lactate) were measured at the 1st and 24th hours.For micronutrient analysis, blood samples were collected at the 1st hour of ICU admission for all patients. Subsequent sampling was performed at the 24th hour of CRRT for the treatment group and at the 24th hour of ICU stay for the non-CRRT group. Samples were centrifuged at 4000 rpm for 5 minutes and stored at -80°C. Analyzed parameters included:Trace elements: Selenium, zinc, copper, iron.Vitamins: Vitamin B12, Vitamin C, folate.Amino acids: 22 subforms including leucine, isoleucine, valine, and others.Carnitine: Various subforms.CRRT Procedure and Effluent Analysis All CRRT procedures were performed in Continuous Veno-venous Hemodialysis (CVVHD) mode at a dose of 30 mL/kg/hour. An Ultraflux AV1000S polysulfone filter (1.8 m2) was used. Anticoagulation was achieved with unfractionated heparin, and no ultrafiltration was applied during the study period. Dialysate flow rate (Qd) was maintained at 30% of the blood flow rate (Qb) to ensure ideal dialysate saturation, with Qb fixed between 100-140 mL/min.To calculate extracorporeal losses, 20 mL samples were collected from each effluent bag during the 24-hour CRRT period and stored at -80°C. Total loss was calculated by multiplying the concentration in each bag by its total volume. Due to instability under light and room temperature, vitamins (C and B12) were excluded from effluent analysis to avoid confounding results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18-90 years) admitted to a 36-bed general Intensive Care Unit (ICU) in a tertiary education and research hospital. The population focuses on patients diagnosed with Acute Kidney Injury (AKI) Stage 2 or 3 according to the KDIGO clinical practice guidelines. Participants are selected from patients who require an evaluation for Continuous Renal Replacement Therapy (CRRT) within the first hour of their ICU admission. The cohort includes a diverse range of critically ill patients, excluding those with end-stage chronic conditions or specific comorbidities that could confound the analysis of micronutrient clearance
Key inclusion criteria (3 listed)
- Patients aged 18-90 years
- Diagnosis of AKI Stage 2 or 3 according to KDIGO
- Evaluation for CRRT requirement within the first hour of ICU admission.
Key exclusion criteria (8 listed)
- End-stage renal disease or history of chronic RRT
- AKI due to dialyzable toxins,Child-Pugh C liver cirrhosis
- Terminal malignancy,AKI secondary to cardiac arrest
- High risk of mortality within the first 24 hours
- Prior RRT for the current AKI episode,History of kidney transplantation
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 |
|---|---|---|
| Continuous Renal Replacement Therapy (CRRT)atients receive CRRT in Continuous Veno-venous Hemodialysis (CVVHD) mode with a target dose of 30 mL/kg/hour. The procedure uses a polysulfone Ultraflux AV1000S filter with a surface area of 1.8 m2. Anticoagulation is provided with unfractionated heparin. Blood flow rate (Qb) is set between 100-140 mL/min, and dialysate flow rate (Qd) is adjusted to 30% of Qb to ensure optimal saturation | Procedure or surgery | – |
| Standard of Care (Non-CRRT Management)Patients with Stage 2-3 AKI who do not meet the criteria for CRRT or are managed with conservative medical therapy according to the attending clinician's decision. These patients receive routine ICU care without extracorporeal treatment. | Other | – |
Primary outcome
Extracorporeal Clearance of Micronutrients and Carnitine
Time frame: At the 24th hour of Continuous Renal Replacement Therapy (CRRT)
Calculation of the clearance rates for trace elements (selenium, zinc, copper, iron), carnitine subforms, and 22 different amino acids by analyzing their concentrations in the blood and effluent (waste fluid) during the 24-hour Continuous Renal Replacement Therapy (CRRT) period.
5 secondary outcomes
Changes in Serum Carnitine Concentrations
Time frame: Baseline (1st hour of admission) and 24 hours
comparison of serum amino acid concentration
Time frame: first hour of intensive care unite admission and the 24th hour
comparison of serum vitamins(B12,folat) concentrations
Time frame: first hour of intensive care admission and the 24 th hour
The difference in micronutrient status between patients receiving and not receiving CRRT.
Time frame: 24 hours after hospital admission/start of treatment.
Clinical Correlation
Time frame: Through study completion (up to 24 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publication: PubMed 35871932Fah M, Van Althuis LE, Ohnuma T, Winthrop HM, Haines KL, Williams DGA, Krishnamoorthy V, Raghunathan K, Wischmeyer PE. Micronutrient deficiencies in critically ill patients receiving continuous renal replacement therapy. Clin Nutr ESPEN. 2022 Aug;50:247-254. doi: 10.1016/j.clnesp.2022.05.008. Epub 2022 May 23.
- Results publication: PubMed 37306546Koekkoek KWA, Berger MM. An update on essential micronutrients in critical illness. Curr Opin Crit Care. 2023 Aug 1;29(4):315-329. doi: 10.1097/MCC.0000000000001062. Epub 2023 Jun 8.
- Results publication: PubMed 35365361Berger MM, Shenkin A, Schweinlin A, Amrein K, Augsburger M, Biesalski HK, Bischoff SC, Casaer MP, Gundogan K, Lepp HL, de Man AME, Muscogiuri G, Pietka M, Pironi L, Rezzi S, Cuerda C. ESPEN micronutrient guideline. Clin Nutr. 2022 Jun;41(6):1357-1424. doi: 10.1016/j.clnu.2022.02.015. Epub 2022 Feb 26.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury (Nontraumatic) and Critical Illness, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 16 Mar 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracorporeal Clearance of Micronutrients and Carnitine (time frame: At the 24th hour of Continuous Renal Replacement Therapy (CRRT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07467889, which also lists 3 linked publications.
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 16 Mar 2026.