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

February 8, 2017 updated by: University of Edinburgh

The Use of Urinary MALDI-MS in Predicting Post-Operative Acute Kidney Injury in Patients After Fixation of Fractured Neck of Femur.

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?

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients over 50 years old who have suffered fractured neck of the femur

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal of Consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Kidney Injury
Time Frame: Within 7 days
Defined by KDIGO Criteria
Within 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2017

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC16138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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