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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03156426
Other study ID # AC16143
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2017
Est. completion date November 15, 2017

Study information

Verified date June 2018
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Intervention

Other:
Event of interest: Acute kidney injury
AKI as defined by AKIN staging

Locations

Country Name City State
United Kingdom Royal Infirmary of Edinburgh Edinburgh

Sponsors (2)

Lead Sponsor Collaborator
University of Edinburgh NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma level of kidney injury molecule-1 (KIM-1) to predict risk of developing AKI - a novel biomarker of early kidney injury 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. 30 days
Secondary Plasma level of kidney injury molecule-1 (KIM-1) to identify AKI on admission 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. 30 days
Secondary Plasma level of kidney injury molecule-1 (KIM-1) to identify patients with a greater risk of mortality 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 30 days
Secondary Rate of change in plasma level of kidney injury molecule-1 (KIM-1) between admission and day 2 to predict risk of AKI 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. 30 days
Secondary 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 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 30 days
Secondary Protein-creatinine ratio (PCR): The ratio of protein to creatinine in the urine 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 30 days
Secondary Urinary liver-fatty acid binding protein (urinary L-FABP) 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 30 days
Secondary Urinary kidney injury molecule-1 (KIM-1) 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 30 days.
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