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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Wuerzburg University Hospital
Sponsor:
Information provided by (Responsible Party):
Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT01552525
First received: February 2, 2012
Last updated: March 8, 2012
Last verified: March 2012
  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
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

Resource links provided by NLM:


Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
acute kidney injury
Patients with acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network)

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
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552525

Contacts
Contact: Boris B Betz, Dr +49 931 201 40715 betz_b@medizin.uni-wuerzburg.de

Locations
Germany
University Hospital of Wuerzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Boris B Betz, Dr    +49 931 201 40715    betz_b@medizin.uni-wuerzburg.de   
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
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
Wounds and Injuries
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 July 22, 2014