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NCT02642731 Clinical Trial

Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty

Acute Kidney Injury Clinical Trial

— dexpolvi  

Official title:
Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty- a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02642731
Other study ID # 2013-03-07
Secondary ID
Status Completed
Phase N/A
First received December 25, 2015
Last updated February 25, 2018
Start date September 2013
Est. completion date December 2015

Study information
Verified date February 2018
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sensitive renal markers have been studied abundantly in connection with open heart, liver and transplantation surgery; however in major orthopaedic surgery their use is anecdotal. The aim of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type fatty acid-binding protein), and IL-18 (interleukin -18), in patients coming for elective TKA (total knee arthroplasty) as a pilot study before large study concerning acute kidney injury in orthopaedic surgery.

Description:

Acute renal deterioration is a serious adverse event in elective surgery. Serum creatinine based diagnostics of acute kidney injury may delay diagnosis and produce false negative results since serum creatinine is affected by diet, muscle mass, used hydration therapy. In recent times new markers have been developed and tested in order to find sensitive, fast and reliable marker of renal deterioration.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 50 Years to 75 Years
Eligibility Inclusion Criteria:

- informed consent

- allergy to NSAIDs

Exclusion Criteria:

- no informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Finland Kuopio University Hospital Kuopio Northern Savo

Sponsors (1)
Lead Sponsor Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Renal function S-creatinine, Cystatin C, estimated GFR time zero hours to 48 hours
Secondary Concentraton of sensitive renal markers U-NGAL, P-NGAL, U-KIM-1, U-IL-18 time zero hours to 24 hours
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