Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score (PRAIOC-RISKS)
Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score - a Pilot Feasibility Randomized Controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Background and rationale AKI is common in the intensive care unit .It contributes significantly to mortality and morbidity .the estimated incidence or AKI among critically ill patients is 30-40% and morality is high.
There is a well recognized gap between the optimal care and the delivered care regarding prevention and management of AKI.
The focus over the last few years has been on early detection. A panel of urinary biomarkers have proved helpful for early detection of AKI. However the cost and low specificity make no single one of them solely reliable .using a panel of bio-markers increases their specificity.
The concept of electronic alerts has been recently introduced. Some trials have been testing its impact on the outcome of AKI. The benefit of electronic alerts is still uncertain .A meta-analysis is currently underway to synthesize stronger evidence of electronic alerts benefit.
Another evolving area, is the development of risk score to predict AKI and and hence applying timely preventive measures.
KDIGO recommends applying preventive measures to high risk patients. However no study to date has tested risk scores based interventions
Hypothesis:
We will use the recently validated score to predict AKI in ICU patients. We will then apply preventive measures. To patients at risk .To our knowledge this is the first study to apply preventive interventions based on AKI risk score assessment
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Cairo, Egypt
- Cairo University Hospitals
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
All adult patients (≥18 year old) admitted to the intensive care unit and do not fulfill the criteria for the diagnosis of AKI by Kidney Disease Improving Global Outcome (KDIGO) definition
Exclusion Criteria:
- Patients who have already developed AKI at the time of intensive care unit ICU admission.
- Patients with insufficient medical records to obtain previous medical history
- Patients who lack mental capacity
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Observational
patients will be recruited to this arm to observe prospectively the incidence of AKI among critically ill patients.patients
will receive the standard care.No other intervention will be delivered
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Aktiv komparator: Interventional
Patients in this arm will be subject to AKI risk score.
This risk score was recently developed and validated in Mayo clinic the intervention will be Measures to prevent AKI among critically ill patients
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of AKI
Tidsramme: during 7 days of ICU admission
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We will compare the incidence rate between the interventional and the observational arm
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during 7 days of ICU admission
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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30 day mortality
Tidsramme: 30 days
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all cause mortality during 30 days of ICU admission or within 30 days of developement of AKI
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30 days
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Time to recovery after development of AKI
Tidsramme: 30 days
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Time interval between the diagnosis of AKI and recovery of either blood chemistry or oliguria
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30 days
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Deterioration of AKI stage
Tidsramme: 30 days
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Transition from initial stage KDIGO stage 1 to either 2 or 3 .Transition from initial stage 2 to 3
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30 days
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Duration of dialysis dependency
Tidsramme: 30 days
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time patient remains dialysis-dependant after severe AKI.
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30 days
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KA-13050
Plan for individuelle deltakerdata (IPD)
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