Biomarker Guided Intervention for Prevention of Acute Kidney Injury (BigpAK)
4. maj 2017 opdateret af: Tobias, Bergler, MD, University Hospital Regensburg
Biomarker Guided Intervention to Prevent Development of Acute Kidney Injury in High-risk Surgical Patients
This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients.
Eligible patients are screened for marker of tubular stress in the urine; if patient specific results are above a pre-defined cutoff they are randomized into a standard care group or an interventional group in which patients receive intensified volume therapy.
Studieoversigt
Detaljeret beskrivelse
This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients.Used markers have been identified as markers of tubular stress and have been validated in previous studies with more than 1500 patients.
The advantage of a biomarker guided approach is the saving of time for the diagnosis a developing acute kidney injury (AKI) in high risk surgical patients, since clinical signs of AKI (rise in creatinine/decline of estimated Glomerular Filtration Rate (eGFR), decline of diuresis).
If used biomarkers are above a predefined cutoff within < 4 hours after surgery, patients are randomized in to a standard care population receiving treatment in accordance with Kidney Disease Improving Global Outcomes (KDIGO) guidelines.
In the intervention population patients receive individual volume therapy (= balanced electrolyte solution (Ionosteril)) (1,25 ml/kg bw up to 5 ml/kg bw for 6 hours).
Degree of volume therapy is estimated by several predifined parameters, e.g.
central venous pressure (CVP).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
135
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Regensburg, Tyskland, 93042
- University Hospital Center Regensburg
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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
Beskrivelse
"Inclusion Criteria":
- major surgery with a duration > 4 hours plus one of the following criteria:
- age > 75 years, or
- sepsis, or
- shock, or
- polytrauma, or
- need for invasive ventilation or catecholamines, or
- intra-operative application of contrast-medium, or
- preexisting chronic kidney disease (CKD1-4),
- informed consent
Exclusion Criteria:
- age < 18 years,
- end stage renal disease (ESRD),
- preexisting dialysis,
- withdrawal of consent,
- pregnancy,
- breastfeeding
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: standard care
Patients in the standard care population receive - if biomarkers are elevated -treatment of AKI in accordance with KDIGO 2012 guidelines
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biomarker guided volume substitution with Ionosteril
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Aktiv komparator: interventional care
Patients in the interventional population receive - if biomarkers are elevated - individualized treatment/volume substitution (balanced electrolyte solution = Ionosteril; 1,25-5 ml/kg/bw/6 hours) ) on the basis of predefined criteria
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biomarker guided volume substitution with Ionosteril
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence and severity of AKI in both group
Tidsramme: 90 days
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incidence and severity of AKI according to AKI network definition within 90 days will be monitored
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90 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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need for renal replacement therapy,
Tidsramme: 90 days
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Number of participants with a need for renal replacement therapy (defined as dialysis within 90 days)
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90 days
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length of ICU stay
Tidsramme: 90 days
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overall length of ICU stay
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90 days
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length of hospital stay
Tidsramme: 90 days
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overall length of ICU stay
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90 days
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ICU and hospital costs
Tidsramme: 90 days
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to account for resulting costs, ICU and hospital cost of the standard care and the interventional patient population are monitored
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90 days
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incidence of chronic kidney disease (CKD)
Tidsramme: 90 days
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Investigators want to see if there are any differences on resulting renal function - different stages of chronic kidney disease (CKD I-V) as a consequence of the performed therapy: standard care accoring to KDIGO guidelines versus interventional care
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90 days
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death
Tidsramme: 90 days
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overall mortality
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90 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Tobias Bergler, MD, UKR-Department of Nephrology
- Ledende efterforsker: Ivan Göcze, MD, UKR-Department of Surgery
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
1. juni 2015
Primær færdiggørelse (Faktiske)
1. december 2016
Studieafslutning (Faktiske)
1. januar 2017
Datoer for studieregistrering
Først indsendt
7. juli 2015
Først indsendt, der opfyldte QC-kriterier
14. juli 2015
Først opslået (Skøn)
16. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1476-Version 6
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Akut nyreskade
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Hospital Universitari Son DuretaEspen; This research prize was funded by Nestle Nutrition Institute and...AfsluttetModerat til alvorligt traume, som defineret af en | Injury Severity Score (ISS) > 12 point var inkluderet i undersøgelsen.Spanien