SepsisNCT05739604
Serum Free Amino Acid Concentrations in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)
An observational study of Sepsis and Amino Acid Catabolism Disorder, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Sepsis is a life-threatening condition associated with high morbidity and mortality. The breakdown of proteins mainly from skeletal muscles leads to the release of free amino acids (FAAs). The serum FAA pool has been repeatedly assessed and found to be significantly altered in patients with sepsis/septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Amino Acid Catabolism Disorder
- What is being tested?
- Blood sample analysis
- How many people
- 26 participants
- Where
- 1 sitePoland
- Study dates
- 19 Jun 2020to 15 Dec 2022
- 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: All patients hospitalized in ICU who met inclusion criteria.
Who may be able to join
- over 18 years of age
- present AKI
- requiring renal replacement therapy
- hospitalized at the ICU.
Who cannot join
- acute kidney disease requiring renal replacement therapy prior to admission to the ICU
- chronic kidney disease requiring renal replacement therapy prior to admission to the ICU
- history of past CRRT.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
Gdansk, Pomeranian Voivodeship, 80-210
About this study
Sepsis is a life-threatening condition associated with high morbidity and mortality. The breakdown of proteins mainly from skeletal muscles leads to the release of free amino acids (FAAs). The serum FAA pool has been repeatedly assessed and found to be significantly altered in patients with sepsis/septic shock. Sepsis is well known to be the most common factor contributing to the development of acute kidney injury in critically ill patients.
The investigators want to establish the baseline profile of FAAs and their derivatives in patients with sepsis/septic shock undergoing continuous renal replacement therapy due to sepsis-associated acute kidney injury. Secondly, the investigators want to compare the FAA profiles of the survivors and nonsurvivors.
- Conditions
- Sepsis, Amino Acid Catabolism Disorder
- Being tested
- Blood sample analysis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample analysisDiagnostic test
The concentrations of AAs and related compounds were determined by liquid chromatography/mass spectrometry (LC/MS)
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Patients hospitalized in the Department of Anaesthesiology and Intensive Care with sepsis or septic shock, undergoing continuous renal replacement therapy due to acute kidney injury, in whom the outcome of treatment was survival. Receives: Diagnostic Test: Blood sample analysis | |
| Nonsurvivors | Patients hospitalized in the Department of Anaesthesiology and Intensive Care with sepsis or septic shock, undergoing continuous renal replacement therapy due to acute kidney injury, in whom the outcome of treatment was fatal. Receives: Diagnostic Test: Blood sample analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the baseline profile of FAAs and their derivatives in serum in a group of patients undergoing continuous renal replacement therapy (CRRT) due to sepsis associated acute kidney injury (SA-AKI) in the Intensive care unit (ICU)
Daily analysis of concentrations of amino acids (AA) and related compounds with usage of liquid chromatography/mass spectrometry (LC/MS).
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Comparison the free amino acids (FAA) profile of survivors and nonsurvivors
Daily analysis of concentrations of amino acids (AA) and related compounds with usage of liquid chromatography/mass spectrometry (LC/MS).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start19 Jun 2020
- Primary completion10 Sep 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radosław Owczuk, Medical University of Gdansk
- Investigators
- Radosław Owczuk, Prof., Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739604
- Sponsor's protocol ID
- NKBBN/575/2019
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Free Amino Acid Concentrations in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)
- ClinicalTrials.gov ID
- NCT05739604
- Acronym / sponsor ID
- NKBBN/575/2019
- Conditions
- Sepsis, Amino Acid Catabolism Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 22 Feb 2023 (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.
Sepsis is a life-threatening condition associated with high morbidity and mortality. The breakdown of proteins mainly from skeletal muscles leads to the release of free amino acids (FAAs). The serum FAA pool has been repeatedly assessed and found to be significantly altered in patients with sepsis/septic shock. Sepsis is well known to be the most common factor contributing to the development of acute kidney injury in critically ill patients.
The investigators want to establish the baseline profile of FAAs and their derivatives in patients with sepsis/septic shock undergoing continuous renal replacement therapy due to sepsis-associated acute kidney injury. Secondly, the investigators want to compare the FAA profiles of the survivors and nonsurvivors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Diagnostic Test: Blood sample analysisPatients hospitalized in the Department of Anaesthesiology and Intensive Care with sepsis or septic shock, undergoing continuous renal replacement therapy due to acute kidney injury, in whom the outcome of treatment was survival. |
| Nonsurvivors | – | Diagnostic Test: Blood sample analysisPatients hospitalized in the Department of Anaesthesiology and Intensive Care with sepsis or septic shock, undergoing continuous renal replacement therapy due to acute kidney injury, in whom the outcome of treatment was fatal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients hospitalized in ICU who met inclusion criteria.
Key inclusion criteria (4 listed)
- over 18 years of age
- present AKI
- requiring renal replacement therapy
- hospitalized at the ICU.
Key exclusion criteria (3 listed)
- acute kidney disease requiring renal replacement therapy prior to admission to the ICU
- chronic kidney disease requiring renal replacement therapy prior to admission to the ICU
- history of past CRRT.
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 sample analysisThe concentrations of AAs and related compounds were determined by liquid chromatography/mass spectrometry (LC/MS) | Diagnostic test | Nonsurvivors, Survivors |
Primary outcome
Evaluation the baseline profile of FAAs and their derivatives in serum in a group of patients undergoing continuous renal replacement therapy (CRRT) due to sepsis associated acute kidney injury (SA-AKI) in the Intensive care unit (ICU)
Time frame: Through study completion, an average of 1 year
Daily analysis of concentrations of amino acids (AA) and related compounds with usage of liquid chromatography/mass spectrometry (LC/MS).
1 secondary outcome
Comparison the free amino acids (FAA) profile of survivors and nonsurvivors
Time frame: Through study completion, an average of 1 year
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 22 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Sepsis
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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Radosław Owczuk, Prof. principal investigator
Medical University of Gdansk
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 Sepsis and Amino Acid Catabolism Disorder, run by Medical University of Gdansk at 1 site in Poland.
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 4 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: finished, as of the sponsor's last update on 22 Feb 2023. 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 Poland. 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?
Evaluation the baseline profile of FAAs and their derivatives in serum in a group of patients undergoing continuous renal replacement therapy (CRRT) due to sepsis associated acute kidney injury (SA-AKI) in the Intensive care unit (ICU) (time frame: Through study completion, an average of 1 year). 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 22 Feb 2023.