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

March 2, 2016 updated by: Wuerzburg University Hospital

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Wuerzburg, Germany, 97080
        • University Hospital of Wuerzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
acute kidney injury
Patients with acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks

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
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
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 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)
participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Boris B Betz, Dr, Division of Nephrology Department of Medicine I University Hospital of Wuerzburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

February 2, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (ESTIMATE)

March 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

March 1, 2012

More Information

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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