Inflammatory Mediators of Acute Kidney Injury in Intensiv... | NCT03720860

Studies
Inflammatory Mediators of Acute Kidney Injury in Intensive Care

NCT03720860

Sponsor

Uppsala University

Status

Recruiting

Last Update Posted

Jan 12, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Sepsis
Surgery
Acute Kidney Injury

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

May 2026Estimated

Completion Date

May 2026Estimated

First Submitted Date

Oct 24, 2018

First Submission Date that Met QC Criteria

Oct 24, 2018

First Posted Date

Oct 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2026

Last Update Posted Date

Jan 12, 2026Actual

Name	Class
Maastricht University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Histones	Correlation between levels of histones and degree of acute kidney injury	Within 1 month

Secondary Outcomes

Measure	Description	Time Frame
Other inflammtory mediators	Correlation between levels of other inflammtory mediators and degree of acute kidney injury	Within 1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to the intensive/post operative care unit

with septic shock or
post major surgery or
after intoxication with a chemical compund

Exclusion Criteria:

Pregnancy or
Breast feeding or
Chronic kidney disease or
intoxication with nephrotoxic compund or
lack of informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients subjected to major surgery or intensive care

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sara Bulow, MD	Contact	+46730247414		sara.bulow.anderberg@akademiska.se

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akademiska sjukhuset, Centraloperation	Recruiting	Uppsala	Uppsala County	75185	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39509144	Derived	Karlsson 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.

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes