NCT01552525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2012

Enrollment Period

5.2 years

First QC Date

February 2, 2012

Last Update Submit

March 2, 2016

Conditions

Acute Kidney Injury

Keywords

acute kidney injuryasymmetric dimethylargininesymmetric dimethylargininel-argininearterial stiffnessaugmentation indexpulse wave velocity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (3)

  • 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

  • Associations between ADMA/SDMA serum level and parameters of arterial stiffness

    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

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

Study Arms (1)

acute kidney injury

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network)
  • no started renal replacement therapy (e.g. dialysis)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Wuerzburg

Würzburg, 97080, Germany

Location

Related 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. doi: 10.1186/cc5713.

    PMID: 17331245BACKGROUND

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.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Boris B Betz, Dr

    Division of Nephrology Department of Medicine I University Hospital of Wuerzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2012

First Posted

March 13, 2012

Study Start

January 1, 2011

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 3, 2016

Record last verified: 2012-03

Locations

DE(1)