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

4. april 2022 opdateret af: Marek Janiak, Medical University of Warsaw
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.

Studieoversigt

Status

Rekruttering

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Mazowieckie
      • Otwock, Mazowieckie, Polen, 05-400
        • Rekruttering
        • Gruca Orthopaedic and Trauma Teaching Hospital
        • Kontakt:
          • Marek Janiak
      • Warsaw, Mazowieckie, Polen, 02-005
        • Rekruttering
        • I Department of Anesthesiology and Intensive Care Warsaw Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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)

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • end stage renal disease

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Any stage of acute kidney injury as defined by Kidney Diseases Improving Global Outcome
Tidsramme: 120 hours
Concentration of novel biomarkers, its change and change of renal resistive index considering different stages of acute kidney injury
120 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Kidney perfusion evaluated by Renal Resistive Index (RRI)
Tidsramme: 48 hours
Correlation between RRI and concentration of biomarkers
48 hours
Analysis of proenkephalin concentration
Tidsramme: 24 hours
Change of proenkephalin concentration in the blood sample left at room temperature
24 hours
Kidney dysfunction and mortality
Tidsramme: 30 days
Evaluation of 30-day need for renal replacement therapy, hospitalization due to kidney failure and/or mortality
30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. marts 2022

Primær færdiggørelse (Forventet)

1. november 2023

Studieafslutning (Forventet)

1. november 2023

Datoer for studieregistrering

Først indsendt

21. januar 2022

Først indsendt, der opfyldte QC-kriterier

8. marts 2022

Først opslået (Faktiske)

18. marts 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. april 2022

Sidst verificeret

1. april 2022

Mere information

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