Acute Kidney InjuryNCT06565403
Hyperlactatemia in Critically Ill Patients With Acute Kidney Injury
An observational study of Acute Kidney Injury, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
The aim of the research is to determine the prevalence of patients with acute kidney injury in the intensive care unit, the role of dialysis treatment in the treatment of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 250 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Nov 2022to 19 Aug 2024
- 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
- Adult, Older adult
Study population: All critically ill patients with stage 3 AKI who received RRT were included in the final study cohort.
Who may be able to join
- age >18 years,
- presence of acute kidney injury, stage 3 according to Kidney Disease:Improving Global Outcomes (KDIGO) criteria
- treatment with renal replacement therapy (RRT)
Who cannot join
- patients with chronic kidney disease (CKD) receiving chronic RRT
- previous known malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Critically Ill Patients With Acute Kidney Injury and Dialysis in the Intensive Care Unit
The aim of the research is to determine the prevalence of patients with acute kidney injury in the intensive care unit, the role of dialysis treatment in the treatment of these patients.
Read the detailed description
A retrospective and observational study was conducted in which the investigators included participants who were hospitalised in the Department of Internal Intensive Care Medicine at the University Hospital Maribor and who required replacement haemodialysis treatment during their hospital stay. The decision on haemodialysis treatment was made after an agreement between the attending specialist in intensive care medicine and the nephrologist if there was a clear indication for starting replacement haemodialysis treatment. It should be emphasised that each of the patients received an appropriate form of treatment according to indication and clinical condition, in line with all relevant recommendations and guidelines.
The investigators collected data on the underlying comorbidities, the indication for ICU treatment, the indication for starting haemodialysis treatment, the type of haemodialysis (continuous venovenous haemodialysis, continuous venovenous haemodiafiltration) and the basic parameters of haemodialysis (level of ultrafiltration and total ultrafiltration, anticoagulants used, duration of procedures, complications during haemodialysis, prescribed and achieved haemodialysis dose with emphasis on the amount of dialysate/substitute/ultrafiltrate used (Qe, effluent dose), number of haemodialysis procedures, dialysis membrane used with or without immunoadsorbent membrane). The investigators collected data on laboratory results (haemoglobin, leucocytes, platelets, C-reactive protein, procalcitonin, lactate, urea, creatinine, bilirubin, albumin, partial pressure of oxygen in arterial blood, myoglobin, lactate dehydrogenase, Interleukin-6, beta-2-microglobulin, cystatin C), some measured haemodynamic/vital parameters (mean arterial pressure, diuresis, oxygen demand) and the dose of vasopressor drugs during treatment. The investigators analysed all the data obtained and attempted to objectively evaluate the success of the treatment. The investigators compared different haemodialysis membranes (standard membranes for continuous haemodialysis vs. newer membranes such as Emic-2® and Oxiris membrane®), different dialysis techniques (haemodialysis vs. haemodiafiltration) and the effects of using the Cytosorb® immunoadsorptive membrane. The investigators have obtained data on the duration of hospitalisation and survival of participants after treatment (up to 1 year).
We analysed the data using basic statistical methods, where a value of p < 0.05 is considered statistically significant.
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, lactate, acidosis, survival
- Medical subject headings
- Acute Kidney Injury, Acidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperlactatemia in critically ill patients with acute kidney injury treated with renal replacement therapy in the intensive care unit
survival
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start15 Nov 2022
- Primary completion23 Dec 2023
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maribor, Faculty of Medicine
- Responsible party
- Principal investigator, Robert Ekart, University Medical Centre Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565403
- Sponsor's protocol ID
- UMC Maribor
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make statistical data analysis available.
Publications
Ekart R, Kobal B, Korosec T, Jakopin E, Svensek F, Piko N, Bevc S, Hojs R. Hyperlactatemia in critically ill patients with acute kidney injury treated with renal replacement therapy in the intensive care unit. BMC Nephrol. 2025 Apr 30;26(1):217. doi: 10.1186/s12882-025-04149-5.
PubMed 40307699
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Critically Ill Patients With Acute Kidney Injury and Dialysis in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06565403
- Acronym / sponsor ID
- UMC Maribor
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, lactate, acidosis, survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Collaborators
- University of Maribor, Faculty of Medicine
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 22 Aug 2024 (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.
The aim of the research is to determine the prevalence of patients with acute kidney injury in the intensive care unit, the role of dialysis treatment in the treatment of these patients.
Detailed description
A retrospective and observational study was conducted in which the investigators included participants who were hospitalised in the Department of Internal Intensive Care Medicine at the University Hospital Maribor and who required replacement haemodialysis treatment during their hospital stay. The decision on haemodialysis treatment was made after an agreement between the attending specialist in intensive care medicine and the nephrologist if there was a clear indication for starting replacement haemodialysis treatment. It should be emphasised that each of the patients received an appropriate form of treatment according to indication and clinical condition, in line with all relevant recommendations and guidelines.
The investigators collected data on the underlying comorbidities, the indication for ICU treatment, the indication for starting haemodialysis treatment, the type of haemodialysis (continuous venovenous haemodialysis, continuous venovenous haemodiafiltration) and the basic parameters of haemodialysis (level of ultrafiltration and total ultrafiltration, anticoagulants used, duration of procedures, complications during haemodialysis, prescribed and achieved haemodialysis dose with emphasis on the amount of dialysate/substitute/ultrafiltrate used (Qe, effluent dose), number of haemodialysis procedures, dialysis membrane used with or without immunoadsorbent membrane). The investigators collected data on laboratory results (haemoglobin, leucocytes, platelets, C-reactive protein, procalcitonin, lactate, urea, creatinine, bilirubin, albumin, partial pressure of oxygen in arterial blood, myoglobin, lactate dehydrogenase, Interleukin-6, beta-2-microglobulin, cystatin C), some measured haemodynamic/vital parameters (mean arterial pressure, diuresis, oxygen demand) and the dose of vasopressor drugs during treatment. The investigators analysed all the data obtained and attempted to objectively evaluate the success of the treatment. The investigators compared different haemodialysis membranes (standard membranes for continuous haemodialysis vs. newer membranes such as Emic-2® and Oxiris membrane®), different dialysis techniques (haemodialysis vs. haemodiafiltration) and the effects of using the Cytosorb® immunoadsorptive membrane. The investigators have obtained data on the duration of hospitalisation and survival of participants after treatment (up to 1 year).
We analysed the data using basic statistical methods, where a value of p < 0.05 is considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All critically ill patients with stage 3 AKI who received RRT were included in the final study cohort.
Key inclusion criteria (3 listed)
- age >18 years,
- presence of acute kidney injury, stage 3 according to Kidney Disease:Improving Global Outcomes (KDIGO) criteria
- treatment with renal replacement therapy (RRT)
Key exclusion criteria (2 listed)
- patients with chronic kidney disease (CKD) receiving chronic RRT
- previous known malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hyperlactatemia in critically ill patients with acute kidney injury treated with renal replacement therapy in the intensive care unit
Time frame: 90 days
survival
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 23 Aug 2024.
- Derived from this study: PubMed 40307699Ekart R, Kobal B, Korosec T, Jakopin E, Svensek F, Piko N, Bevc S, Hojs R. Hyperlactatemia in critically ill patients with acute kidney injury treated with renal replacement therapy in the intensive care unit. BMC Nephrol. 2025 Apr 30;26(1):217. doi: 10.1186/s12882-025-04149-5.
- Individual participant dataSharing planned: Yes. There is a plan to make statistical data analysis available.
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Acute Kidney Injury and Ultra-endurance Running
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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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. 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, run by University Medical Centre Maribor at 1 site in Slovenia.
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 2 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 23 Aug 2024. 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 Slovenia. 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?
Hyperlactatemia in critically ill patients with acute kidney injury treated with renal replacement therapy in the intensive care unit (time frame: 90 days). 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 NCT06565403, which also lists 1 linked publication.
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 23 Aug 2024.