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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552525
• Other study ID #: 91/10
• Status: Completed
• Phase: N/A
• First received: February 2, 2012
• Last updated: March 2, 2016
• Start date: January 2011
• Est. completion date: March 2016

Study information

• Verified date: March 2012
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
Germany	University Hospital of Wuerzburg	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in serum ADMA level between acute kidney injury and renal recovery		participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks	No
Primary	Difference in serum SDMA level between acute kidney injury and renal recovery		participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks	No
Secondary	Associations between ADMA/SDMA serum level and all cause mortality		participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks	No
Secondary	Associations between ADMA/SDMA serum level and parameters of arterial stiffness	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	No
Secondary	Associations between ADMA/SDMA serum level and parameters of renal function	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	No