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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01552525
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):

February 2, 2012
March 13, 2012
March 3, 2016
January 2011
March 2016   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Same as current
Complete list of historical versions of study NCT01552525 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
    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 ]
    Parameters of renal function include serum creatinine and estimated Glomerular Filtration Rate (eGFR)
Same as current
Not Provided
Not Provided
 
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
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
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.
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.
Acute Kidney Injury
Not Provided
acute kidney injury
Patients with acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network)
Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
March 2016
March 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01552525
91/10
No
Not Provided
Not Provided
Wuerzburg University Hospital
Wuerzburg University Hospital
Not Provided
Principal Investigator: Boris B Betz, Dr Division of Nephrology Department of Medicine I University Hospital of Wuerzburg
Wuerzburg University Hospital
March 2012