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Completed

NCT Number: NCT03049150

PREdicting RENAL Injury In Patient After Hip Fracture Surgery

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?

Completed

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Lothian

Edinburgh, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal of Consent

Treatment and study plan

Primary outcomes

  1. Acute Kidney Injury

    Time frame: Within 7 days

    Defined by KDIGO Criteria

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

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

Acronym: PRE-RENAL

Important dates

Study start
2017
Primary completion
2017
Study completion
2020
First posted
Feb 9, 2017
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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