New Prognostic Kidney Function Markers in Emergency Patients New Markers of Kidney Function in ED Patients

Sponsor
Krankenhaus Barmherzige Brüder, Regensburg (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02261909
Collaborator
Astute Medical, Inc. (Industry)
0
1
13
0

Study Details

Study Description

Brief Summary

NephroCheck is measuring the concentration of a certain protein combination in the urine of patients. In elevated values there is a probability of renal failure (already proven in intensive care patients). The investigators would like to investigate whether the investigators can predict renal failure in patients receiving contrast enhanced CT's in the emergency department. That would lead to an earlier nephrologist consult in those patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The use of contrast agents can - especially in already in impaired renal function - lead to a decline in real function. The contrast enhanced CT is especially in emergency patients an important diagnostic tool for example in the detection of pulmonary embolism or mesenteric ischemia. Creatinine has been used as a marker for real function so far. But the investigators all know that creatinine is not a perfect marker especially as it is influenced by age, sex, weight and muscle mass. Especially in the diagnosis of acute renal failure creatinine does not allow and recent change in the kidney function.

    This prospective, unicentric study should therefore investigate two new markers in emergency patients who need an emergency contrast enhanced CT to early predict pending kidney function decline.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    New Prognostic Kidney Function Markers in Emergency Patients
    Study Start Date :
    May 1, 2015
    Anticipated Primary Completion Date :
    May 1, 2016
    Anticipated Study Completion Date :
    Jun 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    normal creatinine

    pts receiving an iv-contrast enhanced CT with normal baseline renal function

    elevated creatinine

    pts receiving an iv-contrast enhanced CT with abnormal baseline renal function

    Outcome Measures

    Primary Outcome Measures

    1. Renal function [participants will be followed for the duration of hospital stay, an expected average of 7 days]

      renal function at discharge from hospital (creatinine and BUN measured at day of discharge)

    Secondary Outcome Measures

    1. Requirement for dialysis [participants will be followed for the duration of hospital stay, an expected average of 7 days]

      dialysis required throughout hospital stay

    2. Admission to ICU [participants will be followed for the duration of hospital stay, an expected average of 7 days]

      admission to ICU required throughout hospital stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients in the emergency department who have the indication for contrast enhanced CT and a predicted hospital admission time of 48 hours or longer.
    Exclusion Criteria:
    • children, pregnant women

    • dialysis

    • patients with kidney transplants

    • patients on steroids or further immunocompromised

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Krankenhaus Barmherzige Brueder Regensburg Bavaria Germany 93049

    Sponsors and Collaborators

    • Krankenhaus Barmherzige Brüder, Regensburg
    • Astute Medical, Inc.

    Investigators

    • Study Chair: Jan Braess, Prof, Krankenhaus Barmherzige Brüder

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Krankenhaus Barmherzige Brüder, Regensburg
    ClinicalTrials.gov Identifier:
    NCT02261909
    Other Study ID Numbers:
    • 1
    First Posted:
    Oct 10, 2014
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Keywords provided by Krankenhaus Barmherzige Brüder, Regensburg
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2022