L-Arginine, Symmetrical and Asymmetrical Dimethylarginine (SDMA/ADMA) in Acute Kidney Injury (AKI)

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT01552525
• Lead Sponsor: Wuerzburg University Hospital

Brief Summary

The purpose of the study is to determine the association between acute kidney injury and serum levels symmetrical and asymmetrical dimethylarginine (SDMA/ADMA) and their assumptive influence on mortality, renal function and on arterial stiffness.

Detailed Description

Acute kidney injury (AKI) is a frequent complication with severe implications deteriorating overall prognosis. Nitric oxide (NO)-signal transduction plays an important role in mediating renal damage. NO is produced by NO-synthase (NOS) with L-arginine as its substrate. Endogenous L-Arginine derivatives, asymmetric and symmetric dimethylarginines (ADMA/SDMA), inhibit NO-production directly (AMDA) by blocking NOS activity or indirectly (SDMA) by blocking cellular L-Arginine uptake.

It is well known that SDMA and ADMA are markers of renal function (SDMA) and cardiovascular risk (ADMA/SDMA) in patients with chronic kidney disease (CKD). Moreover, ADMA and SDMA possibly even trigger cardiovascular risk in patients with CKD. However, there is only little information about the regulation and the influence of ADMA/SDMA in acute kidney injury.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-02-02
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-13
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network)
• no started renal replacement therapy (e.g. dialysis)

Exclusion Criteria

• dialysis or continuous venovenous hemofiltration before recruitment
• no recovery from kidney injury according to the definition of AKIN (Acute Kidney Injury Network)
• palliative care
• life expectancy is severely limited (< six months) due to preexisting malignancy or other disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in serum SDMA level between acute kidney injury and renal recovery	participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
Difference in serum ADMA level between acute kidney injury and renal recovery	participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks

Secondary Outcome Measures

Name	Time	Method
Associations between ADMA/SDMA serum level and parameters of arterial stiffness	participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks	Parameters of arterial stiffness include augmentation index and pulse wave velocity
Associations between ADMA/SDMA serum level and parameters of renal function	participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks	Parameters of renal function include serum creatinine and estimated Glomerular Filtration Rate (eGFR)
Associations between ADMA/SDMA serum level and all cause mortality	participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks

Trial Locations

Locations (1)

University Hospital of Wuerzburg; 🇩🇪 Wuerzburg, Germany