NCT02470507

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jun 2013Dec 2026

Study Start

First participant enrolled

June 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

9.2 years

First QC Date

June 10, 2015

Last Update Submit

January 22, 2024

Conditions

Acute Kidney Failure

Outcome Measures

Primary Outcomes (1)

  • Phenotypic characteristics and function of leukocytes

    7 days

Secondary Outcomes (7)

  • Differences in phenotypic characterisation and function of neutrophils between AKI stage II and III.

    7 days

  • Differences in phenotypic characterisation and function of neutrophils between AKI and no AKI

    7 days

  • Differences in cytokine profiles between AKI + SIRS and AKI without SIRS

    7 days

  • Differences in cytokine profiles between SIRS + AKI and SIRS without AKI

    7 days

  • Correlation between microRNA levels in patients with AKI and renal recovery

    7 days

  • +2 more secondary outcomes

Study Arms (4)

AKI with SIRS

Patients with AKI stage II or III and systemic inflammation without sepsis

Other: AKI

AKI without SIRS

Patients with AKI stage II or III and no systemic inflammation

Other: AKI

SIRS without AKI

Patients with systemic inflammation and normal renal function

Other: AKI

No SIRS and no AKI

Patients after major surgery who do not have an infection, SIRS or AKI

Other: AKI

Interventions

AKIOTHER

development of immune dysregulation and rise in inflammatory markers and activation of immune cells

AKI with SIRSAKI without SIRSNo SIRS and no AKISIRS without AKI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalised patients

You may qualify if:

  • Adult patients (≥ 18 years) admitted to the hospital (incl ICU) with one of the following:
  • postoperative AKI II or III and systemic inflammation without sepsis
  • systemic inflammation and normal renal function
  • AKI II or III without systemic inflammation
  • post-surgery with normal renal function and without SIRS or an infection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas Foundation Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

  • Weller S, Varrier M, Ostermann M. Lymphocyte Function in Human Acute Kidney Injury. Nephron. 2017;137(4):287-293. doi: 10.1159/000478538. Epub 2017 Jun 30.

    PMID: 28662513DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Marlies Ostermann

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 12, 2015

Study Start

June 1, 2013

Primary Completion

August 1, 2022

Study Completion (Estimated)

December 1, 2026

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)