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
|Condition or disease||Intervention/treatment|
|Acute Kidney Injury Liver Cirrhoses Biomarkers||Other: Event of interest: Acute kidney injury|
|Study Type :||Observational|
|Actual Enrollment :||52 participants|
|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|
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
- 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.
- 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.
- 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
- 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.
- 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
- 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
- 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
- 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
Haematology: FBC, INR Biochemistry: U&E, LFT Plasma - biomarkers: KIM-1 Urine - proteinuria, fractional excretion of sodium Urinary biomarkers - KIM-1, L-FABP
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
|Royal Infirmary of Edinburgh|
|Edinburgh, United Kingdom, EH164SB|
|Principal Investigator:||Jonathan A Fallowfield, PhD||MRC Centre for Inflammation Research, Queens Medical Research Institute|