SepsisPronMedNCT03720860
Inflammatory Mediators of Acute Kidney Injury in Intensive Care
An observational study of Sepsis and Surgery, run by Uppsala University at 1 site in Sweden.
Trial summary
Acute kidney injury (AKI) affects more than 50% of patients admitted to the intensive care unit. The most common underlying cause is sepsis. Severe AKI in combination with sepsis is associated with high mortality. The mechanisms for sepsis-induced AKI are largely unknown. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Surgery, Acute Kidney Injury
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2018to May 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients subjected to major surgery or intensive care
Who may be able to join
- Patients admitted to the intensive/post operative care unit
- with septic shock or
- post major surgery or
- after intoxication with a chemical compund
Who cannot join
- Pregnancy or
- Breast feeding or
- Chronic kidney disease or
- intoxication with nephrotoxic compund or
- lack of informed consent
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
Akademiska sjukhuset, Centraloperation
Uppsala, Uppsala County, 75185
Robert Frithiof, MD PhD, 0736563473, robert.frithiof@surgsci.uu.se
Sara Bulow, MD
About this study
Official title: Prospective Studie of Inflammatory Markers in Urine, Plasma and Sputum Associated With Acute Kidney Injury
Acute kidney injury (AKI) affects more than 50% of patients admitted to the intensive care unit. The most common underlying cause is sepsis. Severe AKI in combination with sepsis is associated with high mortality. The mechanisms for sepsis-induced AKI are largely unknown. Our hypothesis is that the inflammatory response to an infection cause collateral damage to host tissue and contributes to the development of AKI. In this study we want to investigate the presence of novel inflammatory mediators in patients with sepsis, patients subjected to major surgery (sterile inflammation) and non-inflamed patients and correlate their levels with the risk for AKI.
- Conditions
- Sepsis, Surgery, Acute Kidney Injury
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Patients admitted to the intensive care unit with sepsis | |
| Surgery | Patinets subjected to major surgery and then admitted to the intensive care unit | |
| Non-inflamed | Otherwise healthy patients admitted to the intensive care unit because of intoxication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histones
Correlation between levels of histones and degree of acute kidney injury
Measured: Within 1 month
Secondary outcomes (1)
Other inflammtory mediators
Correlation between levels of other inflammtory mediators and degree of acute kidney injury
Measured: Within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Jan 2018
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Robert Frithiof, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720860
- Sponsor's protocol ID
- 2017-043PronMed
- Acronym
- PronMed
- Status last verified
- Jan 2026
- First submitted
- 24 Oct 2018
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karlsson PA, Zhang T, Jarhult JD, Joffre E, Wang H. Heterogeneity and metabolic diversity among Enterococcus species during long-term colonization. Microbiol Spectr. 2025 Aug 5;13(8):e0316024. doi: 10.1128/spectrum.03160-24. Epub 2025 Jun 12.
PubMed 40503823Karlsson PA, Bolin C, Spang L, Frithiof R, Hultstrom M, Lipcsey M, Wang H, Jarhult JD. Bacteriuria and antibiotic use during the third wave of COVID-19 intensive care in Sweden. Infect Dis (Lond). 2025 Mar;57(3):284-293. doi: 10.1080/23744235.2024.2423884. Epub 2024 Nov 7.
PubMed 39509144
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Studie of Inflammatory Markers in Urine, Plasma and Sputum Associated With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03720860
- Acronym / sponsor ID
- PronMed / 2017-043PronMed
- Conditions
- Sepsis, Surgery, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 25 Oct 2018 (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 (AKI) affects more than 50% of patients admitted to the intensive care unit. The most common underlying cause is sepsis. Severe AKI in combination with sepsis is associated with high mortality. The mechanisms for sepsis-induced AKI are largely unknown. Our hypothesis is that the inflammatory response to an infection cause collateral damage to host tissue and contributes to the development of AKI. In this study we want to investigate the presence of novel inflammatory mediators in patients with sepsis, patients subjected to major surgery (sterile inflammation) and non-inflamed patients and correlate their levels with the risk for AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | –Patients admitted to the intensive care unit with sepsis |
| Surgery | – | –Patinets subjected to major surgery and then admitted to the intensive care unit |
| Non-inflamed | – | –Otherwise healthy patients admitted to the intensive care unit because of intoxication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients subjected to major surgery or intensive care
Key inclusion criteria (4 listed)
- Patients admitted to the intensive/post operative care unit
- with septic shock or
- post major surgery or
- after intoxication with a chemical compund
Key exclusion criteria (5 listed)
- Pregnancy or
- Breast feeding or
- Chronic kidney disease or
- intoxication with nephrotoxic compund or
- lack of informed consent
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
Histones
Time frame: Within 1 month
Correlation between levels of histones and degree of acute kidney injury
1 secondary outcome
Other inflammtory mediators
Time frame: Within 1 month
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 12 Jan 2026.
- Derived from this study: PubMed 40503823Karlsson PA, Zhang T, Jarhult JD, Joffre E, Wang H. Heterogeneity and metabolic diversity among Enterococcus species during long-term colonization. Microbiol Spectr. 2025 Aug 5;13(8):e0316024. doi: 10.1128/spectrum.03160-24. Epub 2025 Jun 12.
- Derived from this study: PubMed 39509144Karlsson PA, Bolin C, Spang L, Frithiof R, Hultstrom M, Lipcsey M, Wang H, Jarhult JD. Bacteriuria and antibiotic use during the third wave of COVID-19 intensive care in Sweden. Infect Dis (Lond). 2025 Mar;57(3):284-293. doi: 10.1080/23744235.2024.2423884. Epub 2024 Nov 7.
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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.
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 Surgery, run by Uppsala University 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 4 inclusion and 5 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 12 Jan 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 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 Sara Bulow, MD (+46730247414, sara.bulow.anderberg@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histones (time frame: Within 1 month). 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 NCT03720860, which also lists 2 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 12 Jan 2026.