Trial document




drksid header

  DRKS00003499

Trial Description

start of 1:1-Block title

Title

Evaluation of Novel Biomarkers from Acutely Ill Patients at Risk for Acute Kidney Injury

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Sapphire AST-111

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The objective of this multicenter prospective cohort study is to collect blood and urine samples to identify and validate novel biomarkers from acutely ill patients for the early detection and risk assessment of acute kidney injury (AKI). As the study is observational there will be no impact on the medical management of the patient with minimum risk.

This study will cover a period of about 8 months, approximately 1,000 adult ICU patients at risk for acute kidney injury at ~30 clinical sites. The study targets patients who do not have known moderate or severe acute kidney injury at enrollment, are expected to be in the ICU for at least 48 hours with a urinary catheter as standard care and who have hemodynamic and/or respiratory dysfunction.

Renal function will be classified based on serum creatinine and urine output. Of primary interest are biomarkers for the risk assessment for development of moderate or severe acut kidney disease 24-48 hours prior to significant changes in serum creatinine levels and urine output. Secondary outcomes of interest include need for dialysis, mortality, ICU and hospital length of stay as well as longer-term outcomes such as recovery from acute kidney injury or development of chronic kidney disease.


Data available in the patient’s hospital record as part of standard care will be recorded in the study CRFs. This includes serum creatinine results, urine output data, results of relevant routine laboratory tests, results from renal biopsy or renal ultrasound. ICU and hospital length of stay, dialysis and. At 1, 3 and 9 months health status will also be assessed by phone call.


end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The purpose of this study is to collect blood and urine samples that may help identify and validate biomarkers for the early detection and risk assessment of acute kidney injury (AKI).

For brief summary please see above.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003499
  •   2012/05/18
  •   2010/09/23
  •   no
  •   Approved
  •   151/10, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2010-023138-22 
  •   NCT01209169  (ClinicalTrials.gov)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   N17 -  Acute renal failure
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients in a critical condition caused by polytrauma, surgery, sepsis or similar events are enrolled in this study. Stratification is not applicable. It is essential that the patients show the SOFA-score described above within 24 hours prior to enrolment and the kidneys only show risk of injury at the most. The fluid in and output needs to be closely monitored for up to the next 7 days but for a minimum of 48 hours in ICU and the samples are to be taken within a set time window. Additional health data and acute conditions are recorded as well beyond these 7 days up to 30 days or discharge (whichever comes first). During follow-up at months 1, 3, and 9 months after day 7 the patients will be contacted again to document their health condition, to possibly complete a quality of life questionnaire and if applicable to collect another blood sample.

end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Of primary interest are biomarkers for the risk assessment for development of moderate or severe acute kidney injury (AKI) (RIFLE-I or RIFLE-F; AKIN 2 or AKIN 3), 24-48 hours prior to significant changes in serum creatinine or urine output.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary outcomes of interest include need for dialysis, mortality, ICU and hospital length of stay as well as longer-term outcomes such as recovery from AKI or development of CKD.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   United Kingdom
  •   Sweden
  •   Austria
  •   Canada
  •   France
  •   Spain
  •   Germany
  •   Belgium
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/02/28
  •   1000
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Males and females 21 years of age or older;

Subjects enrolled (first sample collection) from ED or Floor admitted to the ICU within 24 hours of enrollment; Subjects enrolled from ICU admitted to the ICU within the 24 hours prior to enrollment; Expected to remain in the ICU for at least 48 hours after enrollment; Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment; At least one of the following acute conditions within 24 hours prior to enrollment:

(Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300)and/or Cardiovascular SOFA score of ≥ 1 (MAP < 70 mm Hg and/or any vasopressor required).

Patient (or authorized representative) able and willing to provide written informed consent for study participation.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Special populations including women with known pregnancy, prisoners or institutionalized individuals;
Previous renal transplantation;
Known moderate to severe AKI prior to enrollment (e.g., RIFLE-I or RIFLE-F/ AKIN 2 or AKIN 3)
Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment; Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);Patient meets any of the following:Active bleeding with an anticipated need for > 4 units PRBC;Hemoglobin < 7 g/dL;Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Astute Medical, Inc. VP, Clinical & Regulatory Strategy
    • Ms.  Ph.D.  Karin  Hughes 
    • 3550 General Atomics Ct., BLD 2, R 636
    • 92121  San Diego
    • United States
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Astute Medical, Inc. VP, Clinical and Regulatory Strategy
    • Ms.  Ph.D.  Karin  Hughes 
    • 3550 General Atomics Ct, BLD 2, R 636
    • 92121  San Diego
    • United States
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Astute Medical, Inc. VP, Clinical and Regulatory Strategy
    • Ms.  Ph.D.  Karin  Hughes 
    • 3550 General Atomics Ct., BLD 2, R 636
    • 92121  San Diego
    • United States
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Astute Medical Inc., VP, Clinical and Regualatory Strategy
    • Ms.  Ph.D.  Karin  Hughes 
    • 3550 General Atomic Ct., BLD 2, R. 636
    • 92121  San Diego
    • United States
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2012/12/23
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.