Acute Kidney InjuryTPA-AKINCT06064305
Transcriptional and Proteomic Analysis of Acute Kidney Injury
An observational study of Acute Kidney Injury, run by University Hospital Muenster.
Trial summary
Acute kidney injury is associated with worsened outcome for critically ill patients. Sepsis-associated and non-septic cardiothoracic surgery associated AKI have been reported, nonetheless, precise pathomechanistic differences as well as detectability of transcriptional and proteomic changes in correlation with imaging… Read more about this study
- Who is it for?
- Ages 18 to 150 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- No study-specific interventions
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2023to 1 Dec 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 to 150 years
- All sexes
- Adult, Older adult
Study population: AKI patients, nephrectomy patients
Who may be able to join
- study consent;
- KDIGO>=2;
- vasoplegia and/or sepsis or elective nephrectomy.
Who cannot join
- Age<18 years;
- pregnancy/nursing;
- preexisting CKD with eGFR<60m/min;
- dialysis; former ogran transplantation;
- HIV; hematologic malignancies;
- immunsuppression;
- 4h post biopsy non-pausable effective anticoagulation;
- pre-existing coagulopathy
Trial locations and contacts
No sites are listed yet.
Andreas Margraf, MD contact
About this study
Acute kidney injury is associated with worsened outcome for critically ill patients. Sepsis-associated and non-septic cardiothoracic surgery associated AKI have been reported, nonetheless, precise pathomechanistic differences as well as detectability of transcriptional and proteomic changes in correlation with imaging and plasma markers are unclear.
Read the detailed description
Acute kidney injury is a common and detrimental finding in critically ill/sepsis patients as well as non-septic patients post cardiothoracic surgery. In many cases renal replacement therapy is required and an acute kidney injury is linked to increased morbidity and mortality in intensive care patients. Using routinely obtained clinical samples as well as imaging data, this observational trial investigates the transcriptomic and proteomic determinants detectable in septic and non-septic AKI patient subsets and their correlation with outcome and AKI diagnostic parameters.
- Conditions
- Acute Kidney Injury
- Being tested
- No study-specific interventions
- 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.
No study-specific interventionsOther
Septic AKI patients, post-cardiothoracic AKI patients and non-AKI patients undergoing routine nephrectomy. Due to the observational design of the study, no study-specific interventions are performed. The treatment of the patients is completely guided by the responsible ICU physicians and the respective specialists.
| Study group | Role | What they receive |
|---|---|---|
| Septic AKI patients | Septic AKI patients Receives: Other: No study-specific interventions | |
| Non-septic post-cardiothoracic AKI patients | Non-septic post-cardiothoracic surgery AKI patients Receives: Other: No study-specific interventions | |
| non-AKI patients undergoing routine nephrectomy | non-AKI patients undergoing routine nephrectomy Receives: Other: No study-specific interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of transcriptional and proteomic gene regulation in tissue with clinical molecular Imaging and AKI biomarkers.
Proteomic and RNAseq-based multi-omics pattern recognition.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (5)
Further organ failure based on systemic assessment
Occurrence of organ failure based on hospital data including routinely applied scores, laboratory values or clinical examination.
Measured: Through study completion, an average of 1 year.
RRT incidence
incidence of renal replacement therapy
Measured: 28 days
ICU length of stay
Length of stay for ICU
Measured: Through study completion, an average of 1 year.
Hospital length of stay
Hospital length of stay
Measured: Through study completion, an average of 1 year.
Mortality
28 day mortality
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start29 Sep 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (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.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Zarbock, MD, Study chair, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064305
- Sponsor's protocol ID
- AnIt22-03
- Acronym
- TPA-AKI
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptional and Proteomic Analysis of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06064305
- Acronym / sponsor ID
- TPA-AKI / AnIt22-03
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 29 Sep 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 3 Oct 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.
Acute kidney injury is associated with worsened outcome for critically ill patients. Sepsis-associated and non-septic cardiothoracic surgery associated AKI have been reported, nonetheless, precise pathomechanistic differences as well as detectability of transcriptional and proteomic changes in correlation with imaging and plasma markers are unclear.
Detailed description
Acute kidney injury is a common and detrimental finding in critically ill/sepsis patients as well as non-septic patients post cardiothoracic surgery. In many cases renal replacement therapy is required and an acute kidney injury is linked to increased morbidity and mortality in intensive care patients. Using routinely obtained clinical samples as well as imaging data, this observational trial investigates the transcriptomic and proteomic determinants detectable in septic and non-septic AKI patient subsets and their correlation with outcome and AKI diagnostic parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Septic AKI patients | – | Other: No study-specific interventionsSeptic AKI patients |
| Non-septic post-cardiothoracic AKI patients | – | Other: No study-specific interventionsNon-septic post-cardiothoracic surgery AKI patients |
| non-AKI patients undergoing routine nephrectomy | – | Other: No study-specific interventionsnon-AKI patients undergoing routine nephrectomy |
Who may qualify
- Ages
- 18 to 150 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- AKI patients, nephrectomy patients
Key inclusion criteria (3 listed)
Key exclusion criteria (8 listed)
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 |
|---|---|---|
| No study-specific interventionsSeptic AKI patients, post-cardiothoracic AKI patients and non-AKI patients undergoing routine nephrectomy. Due to the observational design of the study, no study-specific interventions are performed. The treatment of the patients is completely guided by the responsible ICU physicians and the respective specialists. | Other | Non-septic post-cardiothoracic AKI patients, Septic AKI patients, non-AKI patients undergoing routine nephrectomy |
Primary outcome
Correlation of transcriptional and proteomic gene regulation in tissue with clinical molecular Imaging and AKI biomarkers.
Time frame: Through study completion, an average of 1 year.
Proteomic and RNAseq-based multi-omics pattern recognition.
5 secondary outcomes
Further organ failure based on systemic assessment
Time frame: Through study completion, an average of 1 year.
RRT incidence
Time frame: 28 days
ICU length of stay
Time frame: Through study completion, an average of 1 year.
Hospital length of stay
Time frame: Through study completion, an average of 1 year.
Mortality
Time frame: 28 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
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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.
Andreas Margraf, MD contact
Alexander Zarbock, MD study chair
University Hospital Muenster
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University Hospital Muenster.
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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Zarbock, MD (+4925183 ext. 47252, zarbock@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of transcriptional and proteomic gene regulation in tissue with clinical molecular Imaging and AKI biomarkers. (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 3 Oct 2023.