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Immune Function in Acute Kidney Injury

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470507
Recruitment Status : Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

The immune response to kidney damage during acute kidney injury (AKI) is an important contributor to the prolonged lack of renal function and progression of kidney injury. Most data related to intrarenal and interorgan pathways in AKI stem from animal research with sometimes conflicting results. Accurate evaluation of these processes in humans and identification of early diagnostic tools are critical for the development of strategies to prevent and attenuate AKI-related morbidity and mortality in patients.

The aim of this study is to evaluate immune function and miRNA expression in hospitalised patients with and without AKI.


Condition or disease Intervention/treatment
Acute Kidney Failure Other: AKI

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Immune Function in Patients With Acute Kidney Injury
Actual Study Start Date : June 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
AKI with SIRS
Patients with AKI stage II or III and systemic inflammation without sepsis
Other: AKI
development of immune dysregulation and rise in inflammatory markers and activation of immune cells

AKI without SIRS
Patients with AKI stage II or III and no systemic inflammation
Other: AKI
development of immune dysregulation and rise in inflammatory markers and activation of immune cells

SIRS without AKI
Patients with systemic inflammation and normal renal function
Other: AKI
development of immune dysregulation and rise in inflammatory markers and activation of immune cells

No SIRS and no AKI
Patients after major surgery who do not have an infection, SIRS or AKI
Other: AKI
development of immune dysregulation and rise in inflammatory markers and activation of immune cells




Primary Outcome Measures :
  1. Phenotypic characteristics and function of leukocytes [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Differences in phenotypic characterisation and function of neutrophils between AKI stage II and III. [ Time Frame: 7 days ]
  2. Differences in phenotypic characterisation and function of neutrophils between AKI and no AKI [ Time Frame: 7 days ]
  3. Differences in cytokine profiles between AKI + SIRS and AKI without SIRS [ Time Frame: 7 days ]
  4. Differences in cytokine profiles between SIRS + AKI and SIRS without AKI [ Time Frame: 7 days ]
  5. Correlation between microRNA levels in patients with AKI and renal recovery [ Time Frame: 7 days ]
    Correlation between microRNA levels in patients with AKI and patient outcome Differences in cytokine profiles between AKI patients without systemic inflammation and patients without AKI and without systemic inflammation / infection.

  6. Correlation between microRNA levels in patients with AKI and patient outcome [ Time Frame: 7 days ]
    Differences in cytokine profiles between AKI patients without systemic inflammation and patients without AKI and without systemic inflammation / infection.

  7. Differences in cytokine profiles between AKI patients without SIRS and patients without AKI and without SIRS [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospitalised patients
Criteria

Inclusion Criteria:

  • Adult patients (≥ 18 years) admitted to the hospital (incl ICU) with one of the following:

    1. postoperative AKI II or III and systemic inflammation without sepsis
    2. systemic inflammation and normal renal function
    3. AKI II or III without systemic inflammation
    4. post-surgery with normal renal function and without SIRS or an infection

Exclusion Criteria:

  • Renal transplant patients
  • Patients on immunosuppressive drugs (except steroids)
  • Patients with haematological malignancy
  • Jehovah's witness

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 ClinicalTrials.gov identifier (NCT number): NCT02470507


Locations
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United Kingdom
Guy's & St Thomas Foundation Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
Investigators
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Principal Investigator: Marlies Ostermann Guy's & St Thomas NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02470507    
Other Study ID Numbers: CSP88220
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases