Evaluation of Novel Biomarkers in Early Recognition of Acute Kidney Injury After Orthopedic Operations.

NCT05285709 | Unknown

• 1 other identifier: BIAKOR
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Surgical treatment of hip fracture may be complicated by acute kidney injury. The aim of this study is to investigate whether the investigators can find a better biomarker than creatinine to recognize this problem at an earlier stage.

Conditions

Hip Fractures; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Any stage of acute kidney injury as defined by Kidney Diseases Improving Global Outcome

  Concentration of novel biomarkers, its change and change of renal resistive index considering different stages of acute kidney injury

  120 hours

Secondary Outcomes (3)

• Kidney perfusion evaluated by Renal Resistive Index (RRI)

  48 hours

• Analysis of proenkephalin concentration

  24 hours

• Kidney dysfunction and mortality

  30 days

Interventions

Biomarker DIAGNOSTIC_TEST

blood and urine sampling before and after surgery (1-admission to operating ward, 2-leaving operation ward, 1st day postop, 2nd day postop, 5th day postop, or the day patient leaves hospital, whichever is first)

RRI measurement DIAGNOSTIC_TEST

patients able to cooperate will have renal resistive index measured before and after surgery (admission to operating ward, leaving operating ward)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patients able to provide informed consent, who do not have diagnosed end stage renal disease undergoing surgical treatment of hip fracture (either joint alloplasty or internal fixation)

You may qualify if:

• age at least 18 years
• be able to provide informed consent

You may not qualify if:

• end stage renal disease

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (2)

Gruca Orthopaedic and Trauma Teaching Hospital

Otwock, Masovian Voivodeship, 05-400, Poland

RECRUITING

I Department of Anesthesiology and Intensive Care Warsaw Medical University

Warsaw, Masovian Voivodeship, 02-005, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

urine and plasma from centrifuged whole blood after partial analysis of biomarkers

MeSH Terms

Conditions

Hip Fractures; Acute Kidney Injury

Interventions

Environmental Biomarkers

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biomarkers; Biological Factors; Biological Phenomena; Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health

Central Study Contacts

Przemysław Bolewski

CONTACT

0048225021721; klinanest1@wum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: March 18, 2022
• Study Start: March 15, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

PL (2)