Acute Kidney InjuryNCT01552525
L-Arginine, Symmetrical and Asymmetrical Dimethylarginine (SDMA/ADMA) in Acute Kidney Injury (AKI)
An observational study of Acute Kidney Injury, run by Wuerzburg University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network)
- no started renal replacement therapy (e.g. dialysis)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, asymmetric dimethylarginine, symmetric dimethylarginine, l-arginine, arterial stiffness, augmentation index, pulse wave velocity
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute kidney injury | Patients with acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in serum ADMA level between acute kidney injury and renal recovery
Measured: 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
Measured: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
Secondary outcomes (3)
Associations between ADMA/SDMA serum level and all cause mortality
Measured: 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
Parameters of arterial stiffness include augmentation index and pulse wave velocity
Measured: 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
Parameters of renal function include serum creatinine and estimated Glomerular Filtration Rate (eGFR)
Measured: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJan 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris B Betz, Dr, Principal investigator, Division of Nephrology Department of Medicine I University Hospital of Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552525
- Sponsor's protocol ID
- 91/10
- Status last verified
- Mar 2012
- First submitted
- 2 Feb 2012
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17331245
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01552525
- Acronym / sponsor ID
- 91/10
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, asymmetric dimethylarginine, symmetric dimethylarginine, l-arginine, arterial stiffness, augmentation index, pulse wave velocity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute kidney injury | – | –Patients with acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network)
- no started renal replacement therapy (e.g. dialysis)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Background: PubMed 17331245Mehta 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.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris B Betz, Dr principal investigator
Division of Nephrology Department of Medicine I University Hospital of Wuerzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01552525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.