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Prognostic Biomarkers For Acute Kidney Injury In Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT03156426
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
Acute kidney injury (AKI) is a common and under-diagnosed problem in patients with liver cirrhosis, and is associated with significant illness and preventable death. Blood (serum) creatinine is the current test for kidney function, but it is an insensitive and non-specific marker in cirrhosis. The investigators hypothesise that blood (plasma) levels of kidney injury molecule-1 (KIM-1) will detect AKI earlier and predict the risk of worsening AKI in cirrhosis, thus identifying patients in need of prompt and effective treatment and improving patient outcomes. The investigators will collect blood and urine samples from cirrhosis patients admitted into hospital and study the relationship between plasma KIM-1, other diagnostic 'biomarker' tests that have recently been proposed, and patient outcomes.

Condition or disease Intervention/treatment
Acute Kidney Injury Liver Cirrhoses Biomarkers Other: Event of interest: Acute kidney injury

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prognostic Biomarkers For Acute Kidney Injury In Liver Cirrhosis
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Group/Cohort Intervention/treatment
Study population
Adults with a histological, clinical or radiological diagnosis of cirrhosis who are admitted to RIE over a 4-month period will be approached by a member of their clinical care team for potential participation. Eligible patients may be recruited from accident and emergency, the acute medical unit, hepatology ward, high dependency or intensive care units. Recurrent admissions are common, so only the first admission for each recruited patient will be included. Patients will be monitored to identify acute kidney injury (AKI) during admission.
Other: Event of interest: Acute kidney injury
AKI as defined by AKIN staging




Primary Outcome Measures :
  1. Plasma level of kidney injury molecule-1 (KIM-1) to predict risk of developing AKI - a novel biomarker of early kidney injury [ Time Frame: 30 days ]
    Plasma KIM-1 is a biomarker of kidney damage. We will measure it on admission and analyse the relationship between admission plasma KIM-1 level and risk of developing AKI during hospital stay.


Secondary Outcome Measures :
  1. Plasma level of kidney injury molecule-1 (KIM-1) to identify AKI on admission [ Time Frame: 30 days ]
    Plasma KIM-1 is a biomarker of kidney damage. We will measure it on admission and analyse the relationship between plasma KIM-1 level and the presence of AKI on admission.

  2. Plasma level of kidney injury molecule-1 (KIM-1) to identify patients with a greater risk of mortality [ Time Frame: 30 days ]
    Plasma KIM-1 is a biomarker of kidney damage. We will measure it on admission and assess the relationship between plasma KIM-1 level on admission and all-cause mortality rate at day 30

  3. Rate of change in plasma level of kidney injury molecule-1 (KIM-1) between admission and day 2 to predict risk of AKI [ Time Frame: 30 days ]
    We will measure plasma KIM-1 on admission, day 1 and day 2 and assess if there is a relationship between change in plasma KIM-1 level (admission + day 2) and risk of developing AKI.

  4. Fractional excretion of sodium (FeNa): a measurement is taken of urine sodium and creatinine concentration, and compared to serum creatinine and sodium to analyse the degree to which the kidneys are retaining sodium [ Time Frame: 30 days ]
    FeNa has been suggested as a suitable marker of AKI in patients with liver cirrhosis. We will use this as a comparative biomarker to plasma KIM-1 at predicting risk of AKI during hospital stay

  5. Protein-creatinine ratio (PCR): The ratio of protein to creatinine in the urine [ Time Frame: 30 days ]
    PCR is the current gold-standard biomarker for chronic kidney disease and can be helpful in the acute setting. We will compare the performance of PCR with plasma-KIM-1 level on admission at predicting the risk of developing AKI during hospital stay

  6. Urinary liver-fatty acid binding protein (urinary L-FABP) [ Time Frame: 30 days ]
    urinary L-FABP is another novel biomarker which has been suggested as a marker of kidney ischaemia. We will compare the diagnostic performance of urinary L-FABP to plasma- KIM-1 for predicting AKI during admission

  7. Urinary kidney injury molecule-1 (KIM-1) [ Time Frame: 30 days. ]
    Urinary levels of KIM-1 increase during AKI for the same reasons that plasma levels of KIM-1 rise. We will compare whether plasma or urinary KIM-1 is more accurate at predicting AKI during admission


Biospecimen Retention:   Samples Without DNA

Blood:

Haematology: FBC, INR Biochemistry: U&E, LFT Plasma - biomarkers: KIM-1 Urine - proteinuria, fractional excretion of sodium Urinary biomarkers - KIM-1, L-FABP



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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

This exploratory study will test recruitment, sample collection, assess size of change and inform power calculations for a larger Scottish multi-centre study.

Adults with a histological, clinical or radiological diagnosis of cirrhosis who are admitted to RIE over a 3-month period will be approached by a member of their clinical care team for potential participation. Eligible patients may be recruited from the acute medical unit, hepatology ward, high dependency or intensive care units.

Criteria

Inclusion Criteria:

  1. Male or female adult subjects over 18 years of age
  2. Able to provide written informed consent and able to understand and willing to comply with the requirements of the study
  3. Clinical/imaging-diagnosed or biopsy-proven liver cirrhosis of any aetiology
  4. Not previously enrolled in this study on a previous admission

Exclusion Criteria:

1) Those patients who do not have capacity to 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 ClinicalTrials.gov identifier (NCT number): NCT03156426


Locations
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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH164SB
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
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Principal Investigator: Jonathan A Fallowfield, PhD MRC Centre for Inflammation Research, Queens Medical Research Institute
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03156426    
Other Study ID Numbers: AC16143
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual patient data will be available to other researchers

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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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Liver Cirrhosis
Acute Kidney Injury
Fibrosis
Wounds and Injuries
Pathologic Processes
Liver Diseases
Digestive System Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases