L-Arginine, Symmetrical and Asymmetrical Dimethylarginine (SDMA/ADMA) in Acute Kidney Injury (AKI)
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Purpose
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.
| Condition |
|---|
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Acute Kidney Injury |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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 |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]Parameters of arterial stiffness include augmentation index and pulse wave velocity
- 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 ] [ Designated as safety issue: No ]Parameters of renal function include serum creatinine and estimated Glomerular Filtration Rate (eGFR)
Biospecimen Retention: Samples With DNA
Blood and urine samples will be centrifuged. One ml aliquots of plasma, serum, urine and a whole blood sample will be stored at -80°C.
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients with acute kidney injury in the University Hospital of Wuerzburg will be recruited on the wards and in the emergency unit when nephrologists are consulted.
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
Contacts and Locations| Contact: Boris B Betz, Dr | +49 931 201 40715 | betz_b@medizin.uni-wuerzburg.de |
| Germany | |
| University Hospital of Wuerzburg | Recruiting |
| Wuerzburg, Germany, 97080 | |
| Contact: Boris B Betz, Dr +49 931 201 40715 betz_b@medizin.uni-wuerzburg.de | |
| Principal Investigator: | Boris B Betz, Dr | Division of Nephrology Department of Medicine I University Hospital of Wuerzburg |
More Information
Publications:
| Responsible Party: | Wuerzburg University Hospital |
| ClinicalTrials.gov Identifier: | NCT01552525 History of Changes |
| Other Study ID Numbers: | 91/10 |
| Study First Received: | February 2, 2012 |
| Last Updated: | March 8, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Wuerzburg University Hospital:
|
acute kidney injury asymmetric dimethylarginine symmetric dimethylarginine l-arginine |
arterial stiffness augmentation index pulse wave velocity |
Additional relevant MeSH terms:
|
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases N,N-dimethylarginine |
Omega-N-Methylarginine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013