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Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury

8. april 2021 opdateret af: Johan Fridolf Hermansen, Aarhus University Hospital
Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. This study will evaluate the diagnostic ability of ultrasonographic measures of blood flow in kidneys and liver in predicting AKI after cardiac surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. The pathophysiology is multifactorial, but renal functions in this setting is determined by a complex interplay between renal perfusion, fluid status, cardiac output, mean arterial pressure and back pressure to venous outflow.

Renal perfusion may be quantified with novel ultrasound techniques. Ultrasonography of the kidney and renal vasculature allows for assessment of renal afferent flow and renal venous flow and, together with venous flow patterns of the portal vein and liver veins, may identify patients in risk of AKI.

The study is observational and will describe the diagnostic accuracy of the ultrasound measures in predicting postoperative AKI. Patients will be examined with ultrasound of kidney and liver flow along with echocardiography on on the day before surgery and on the 1st and 4th. In addition, patients are followed with markers of kidney function, fluid balance and invasive measures of mean arterial pressure and central venous pressure.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

150

Kontakter og lokationer

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

Studiesteder

  • Danmark
      • Aarhus, Danmark, 8200
        • Aarhus University Hospital, Department of Anaesthesiology
  • Sydafrika
      • Johannesburg, Sydafrika, 2196
        • Department of Anesthesiology, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand

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

Patients scheduled for on-pump cardiac surgery at the Department of Cardiothoracic & vascular surgery, Aarhus University Hospital. The study will include 100 patients from Denmark.

Beskrivelse

Inclusion Criteria:

  • All patients ≥ 18 years
  • Scheduled for on-pump cardiac surgery
  • Oral and written consent

AND

  • 1 of the following risk factors for development of postoperative AKI may be included:

    • age > 70 years;
    • NYHA (New York Heart Association) 3+4;
    • Insulin dependent diabetes;
    • Glomerular filtration rate < 60 ml/min/1,73 m2;
    • Ejection fraction < 35;

    • Surgery:

      • Combined CABG and valve surgery;
      • Any valve surgery except isolated aortic-valve surgery;
      • Redo surgery;
      • Endocarditis;
    • Peripheral vascular disease.

Exclusion Criteria:

  • Insufficient ultrasonographic imaging of the kidneys;
  • Known morphological kidney disease;
  • Preoperative dialysis;
  • Prior participation in the study.

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

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Aarhus University Hospital
100 patients undergoing on-pump cardiac surgery at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
Procedure: On-pump cardiac surgery
All participants will undergo on-pump cardiac surgery
Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
50 patients undergpoing on-pump cardiac surgery at at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
Procedure: On-pump cardiac surgery
All participants will undergo on-pump cardiac surgery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The association between the kidney venous ultrasonography flow pattern category on the 1st postoperative day and acute kidney injury (AKI) on the 4th postoperative day.
Tidsramme: 4 days

The flow pattern is grouped as either continuous, biphasic or monophasic based on the appearance.The final analysis will possibly include other flow categories.

AKI is defined by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria and graded in four stages from no AKI to stage 1-3 AKI based on serum creatinin change and/or changes in urine output, with stage 3 being the worst stage.
4 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between changes in organ-specific flow measurements and the corresponding biomarkers.
Tidsramme: 1 month
Correlations between organ-specific ultrasonography flow measurements and the corresponding biomarkers of kidneys, liver and heart function, for both absolute values of organ-specific flow and perioperative changes in organ-specific flow
1 month
Establishment of the most optimal organ specific cut-off values and the development of AKI.
Tidsramme: 1 month

Establishment of the most optimal cut-off (threshold) values for

  • absolute ultrasonography flow values for respectively kidney arterial flow; kidney venous flow; liver vein flow; portal vein flow and the risk of development of AKI.
  • changes in ultrasonography flow values for respectively kidney arterial flow; kidney venous flow; liver vein flow; portal vein flow and the risk of development of AKI.
1 month
Fluid balance and AKI
Tidsramme: 1 month
Correlations between accumulated fluid balance on the 1st postoperative day and the development of AKI on the 4th postoperative day.
1 month
Diastolic dysfunction and AKI
Tidsramme: 1 month
Correlations between echocardiographic measures of diastolic dysfunction and AKI. The measures include mitral inflow (E and A), mitral annular motion, medial and lateral (e' and a'), and measures define grades of diastolic dysfunction from normal to grade I-III, with grade III being the worst.
1 month
Organ-specific flow measures and mortality
Tidsramme: 1 month
Correlation between organ-specific ultrasonography flow measurements on the day before surgery, the 1st and 4th postoperative day and the mortality at the 1st, 4th and 28th postoperative day.
1 month
Organ-specific flow measures and and time of stay in ICU and hospital
Tidsramme: 1 month
Correlation between organ-specific ultrasonography flow measurements on the day before surgery, the 1st and 4th postoperative day and the duration of intensive care stay and duration of hospital stay.
1 month

Samarbejdspartnere og efterforskere

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

Sponsor

Aarhus University Hospital

Samarbejdspartnere

University of Aarhus

Efterforskere

  • Studiestol: Peter Juhl-Olsen, MD, PhD, Department of Anaesthesiology, Aarhus University Hospital

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. oktober 2018

Primær færdiggørelse (Faktiske)

31. marts 2020

Studieafslutning (Faktiske)

31. marts 2020

Datoer for studieregistrering

Først indsendt

9. oktober 2018

Først indsendt, der opfyldte QC-kriterier

30. oktober 2018

Først opslået (Faktiske)

1. november 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1-10-72-267-18

Plan for individuelle deltagerdata (IPD)

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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