Inflammatory Mediators of Acute Kidney Injury in Intensive Care

NCT03720860 | Recruiting

• 1 other identifier: 2017-043PronMed
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Surgery; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Histones

  Correlation between levels of histones and degree of acute kidney injury

  Within 1 month

Secondary Outcomes (1)

• Other inflammtory mediators

  Within 1 month

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients subjected to major surgery or intensive care

You may qualify if:

• Patients admitted to the intensive/post operative care unit
• with septic shock or
• post major surgery or
• after intoxication with a chemical compund

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead
• Maastricht University: collaborator

Study Sites (1)

Akademiska sjukhuset, Centraloperation

Uppsala, Uppsala County, 75185, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sputum Blood Urine

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Sara Bulow, MD

CONTACT

+46730247414; sara.bulow.anderberg@akademiska.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 25, 2018
• Study Start: January 1, 2018
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

SE (1)