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NCT03049150 Clinical Trial

PREdicting RENAL Injury In Patient After Hip Fracture Surgery

Acute Kidney Injury Clinical Trial

— PRE-RENAL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03049150
Other study ID # AC16138
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 3, 2017
Est. completion date January 9, 2020

Study information
Verified date May 2024
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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?

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 9, 2020
Est. primary completion date May 29, 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Fractured Neck of Femur - Age >50 - Informed consent Exclusion Criteria: - Refusal of Consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom NHS Lothian Edinburgh

Sponsors (1)
Lead Sponsor Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute Kidney Injury Defined by KDIGO Criteria Within 7 days
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