- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01552525
L-Arginine, Symmetrical and Asymmetrical Dimethylarginine (SDMA/ADMA) in Acute Kidney Injury (AKI)
Regulation of L-Arginine Und Its Derivatives of Asymmetrical and Symmetrical Dimethylarginine and L-NG Monomethylarginine (ADMA/SDMA/L-NMMA) in Acute Kidney Injury and Correlation to Cardiac, Renal and Vascular Function and Mortality
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Wuerzburg, Germany, 97080
- University Hospital of Wuerzburg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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acute kidney injury
Patients with acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Difference in serum ADMA level between acute kidney injury and renal recovery
Time Frame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
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participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
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Difference in serum SDMA level between acute kidney injury and renal recovery
Time Frame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
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participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Associations between ADMA/SDMA serum level and all cause mortality
Time Frame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
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participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
|
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Associations between ADMA/SDMA serum level and parameters of arterial stiffness
Time Frame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
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Parameters of arterial stiffness include augmentation index and pulse wave velocity
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participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
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Associations between ADMA/SDMA serum level and parameters of renal function
Time Frame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
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Parameters of renal function include serum creatinine and estimated Glomerular Filtration Rate (eGFR)
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participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Boris B Betz, Dr, Division of Nephrology Department of Medicine I University Hospital of Wuerzburg
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 91/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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