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Inflammatory Mediators of Acute Kidney Injury in Intensive Care (PronMed)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03720860
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Maastricht University
Information provided by (Responsible Party):
Robert Frithiof, Uppsala University

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.

Condition or disease
Sepsis Surgery Acute Kidney Injury

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Studie of Inflammatory Markers in Urine, Plasma and Sputum Associated With Acute Kidney Injury
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Patients admitted to the intensive care unit with sepsis
Patinets subjected to major surgery and then admitted to the intensive care unit
Otherwise healthy patients admitted to the intensive care unit because of intoxication.

Primary Outcome Measures :
  1. Histones [ Time Frame: Within 1 month ]
    Correlation between levels of histones and degree of acute kidney injury

Secondary Outcome Measures :
  1. Other inflammtory mediators [ Time Frame: Within 1 month ]
    Correlation between levels of other inflammtory mediators and degree of acute kidney injury

Biospecimen Retention:   Samples With DNA
Sputum Blood Urine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients subjected to major surgery or intensive care

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03720860

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Contact: Sara Bulow, MD +46730247414

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Akademiska sjukhuset, Centraloperation Recruiting
Uppsala, Sweden, 75185
Contact: Robert Frithiof, MD PhD    0736563473   
Principal Investigator: Sara Bulow, MD         
Sponsors and Collaborators
Uppsala University
Maastricht University

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Responsible Party: Robert Frithiof, MD, PhD, Uppsala University Identifier: NCT03720860     History of Changes
Other Study ID Numbers: 2017-043PronMed
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases