PREdicting RENAL Injury In Patient After Hip Fracture Surgery (PRE-RENAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03049150
Recruitment Status : Not yet recruiting
First Posted : February 9, 2017
Last Update Posted : February 9, 2017
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
To determine whether MALDI, a type of Mass-Spectometry, can use protein pattern detection within urine to predict postoperative (after an operation) kidney damage in adults who have undergone emergency hip fracture surgery?

Condition or disease
Acute Kidney Injury

Detailed Description:

The PRE-RENAL study is a prognostic accuracy study testing the ability of the MALDI-MS assay to predict incident acute kidney injury after fractured neck of femur surgery. The study aims to validate the findings of a urinary peptide panel previously developed and validated on a cohort of septic patients.

Kidney injury following surgery or as a part of severe illness is an important complication, because it can delay and reduce the chances of recovery. A reliable early test for kidney injury would be useful so that treatments to prevent or minimise it can be started as early as possible. This study, based with a group of medical researchers working with chemists, will analyse clinical urine specimens from patients undergoing major orthopaedic (bone) surgery. We will explore whether patterns of proteins in the urine could be used as an early warning that kidney injury is present before existing tests demonstrate it.

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Urinary MALDI-MS in Predicting Post-Operative Acute Kidney Injury in Patients After Fixation of Fractured Neck of Femur.
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Acute Kidney Injury [ Time Frame: Within 7 days ]
    Defined by KDIGO Criteria

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 50 years old who have suffered fractured neck of the femur

Inclusion Criteria:

  • Fractured Neck of Femur
  • Age >50
  • Informed consent

Exclusion Criteria:

  • Refusal of Consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03049150

Contact: Tim Walsh, MD 01312426395

Sponsors and Collaborators
University of Edinburgh

Responsible Party: University of Edinburgh Identifier: NCT03049150     History of Changes
Other Study ID Numbers: AC16138
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Edinburgh:
Mass Spectometry

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases