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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05285709
Enrollment
200
Registered
2022-03-18
Start date
2022-03-15
Completion date
2023-11-30
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Hip Fractures

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.

Detailed description

Extensive orthopedic surgical procedures may have many postoperative complications. One of those, sometimes overlooked, is acute kidney injury. Classically defined by KDIGO criteria as an increase in creatinine concentration, may go by unnoticed due to a late peak in serum concentration of this marker. There is still need for nephrological troponin which could easily and with a low margin of doubt identify acute kidney injury. The investigators have planned a double-center study, in cooperation with the 'Department of Anesthesiology and Intensive Therapy with the Postoperative Subdivision' of the 'Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP' in Otwock, concentrating on measuring concentration of biomarkers known to indicate acute kidney injury in different situations: Proenkephalin (PENK), Dickkopf-3 (DKK3), circular RNA (circRNA), Liver-type Fatty Acid-binding Protein (L-FABP), Netrin-1, semaphorin 3a, Tissue Inhibitor of Matrix Metalloproteinase-2 (TIMP-2), Insulin-like Growth Factor-binding Protein 7 (IGFBP-7), Retinol-binding Protein-4 (RBP-4) aiming to find a marker, or group of markers that would allow recognition of renal injury at an early stage to help minimize the effect. Patients aged at least 18 years, with a hip fracture undergoing, either hip alloplasty, or internal fixation, after providing informed consent, will be included. Patients with end stage renal disease will be excluded. Blood and urine samples will be collected at 5 points of time: 1 - after admission to the operating ward, 2 - following surgery, before leaving the operating ward, 3 - on the 1st postoperative day, 4 - on the 2nd postoperative day, 5 - on the 5th postoperative day, or the day the patient leaves hospital, whichever is first. Additionally patients who will be able to cooperate will have a renal resistive index measured using ultrasonography. Blood collected from patients, not longer than 8 hours after collection will be tested for PENK concentration (Spingotec GmbH, Berlin, Germany), then plasma obtained from this sample after centrifuging will be frozen together with centrifugated samples of urine in -80 degrees Celsius till analysis. Additionally, if the concentration of PENK is elevated, the same sample will be tested after 8, 12 and 24 hours of staying at room temperature, to define stability of the test from blood sampling till measurement. 30 days after surgery, an attempt to contact the patient or his/her family is going to be made, to check if the patient has developed need for renal replacement therapy or has required hospitalisation due to kidney dysfunction together with a 30 day mortality evaluation.

Interventions

DIAGNOSTIC_TESTBiomarker

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)

DIAGNOSTIC_TESTRRI measurement

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

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* end stage renal disease

Design outcomes

Primary

MeasureTime frameDescription
Any stage of acute kidney injury as defined by Kidney Diseases Improving Global Outcome120 hoursConcentration of novel biomarkers, its change and change of renal resistive index considering different stages of acute kidney injury

Secondary

MeasureTime frameDescription
Kidney perfusion evaluated by Renal Resistive Index (RRI)48 hoursCorrelation between RRI and concentration of biomarkers
Analysis of proenkephalin concentration24 hoursChange of proenkephalin concentration in the blood sample left at room temperature
Kidney dysfunction and mortality30 daysEvaluation of 30-day need for renal replacement therapy, hospitalization due to kidney failure and/or mortality

Countries

Poland

Contacts

Primary ContactPrzemysław Bolewski
klinanest1@wum.edu.pl0048225021721

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026