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Completed

NCT Number: NCT01552525

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Wuerzburg

Würzburg, 97080, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2012
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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