Clinical trial NCT01552525: L-Arginine, Symmetrical and Asymmetrical Dimethylarginine (SDMA/ADMA) in Acute Kidney Injury (AKI)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
asymmetric dimethylarginine
symmetric dimethylarginine
l-arginine
arterial stiffness
augmentation index
pulse wave velocity
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: Difference in serum ADMA level between acute kidney injury and renal recovery
timeFrame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
measure: Difference in serum SDMA level between acute kidney injury and renal recovery
timeFrame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Associations between ADMA/SDMA serum level and all cause mortality
timeFrame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
measure: Associations between ADMA/SDMA serum level and parameters of arterial stiffness
timeFrame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
measure: Associations between ADMA/SDMA serum level and parameters of renal function
timeFrame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital of Wuerzburg
Study officials:
affiliation: Division of Nephrology Department of Medicine I University Hospital of Wuerzburg
name: Boris B Betz, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1186/cc5713.