- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07797114
Predictors of Mortality in Cirrhotic Patients With Acute Kidney Injury
Clinical and Laboratory Predictors of Short-Term Mortality in Cirrhotic Patients With Acute Kidney Injury
Acute kidney injury (AKI) is a common and severe complication in patients with liver cirrhosis, significantly increasing the risk of short-term mortality. Early identification of clinical and laboratory predictors of mortality in these patients is crucial for risk stratification and optimizing clinical management.
This study aims to identify the key clinical parameters (such as the presence of ascites, hepatic encephalopathy, and hemodynamics) and laboratory markers (such as serum creatinine, bilirubin, albumin, sodium, and INR) that predict short-term mortality in cirrhotic patients presenting with AKI. The findings will assist clinicians in recognizing high-risk patients early and tailoring targeted therapeutic interventions .
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Cirrhosis-associated acute kidney injury (AKI) represents a major prognostic milestone in the clinical course of end-stage liver disease. While baseline scoring systems like the Model for End-Stage Liver Disease (MELD) and Child-Pugh score provide overall prognostic value, specific clinical and dynamic laboratory predictors are needed to refine short-term mortality risk assessment in the context of AKI.
Objectives:
- To evaluate the clinical presentation and laboratory parameters of cirrhotic patients at the time of AKI diagnosis.
- To determine independent clinical and laboratory factors associated with short-term mortality.
- To assess the predictive performance of clinical scoring systems in this specific cohort.
Methodology:
This observational study will enroll patients diagnosed with liver cirrhosis and AKI based on International Club of Ascites (ICA-AKI) criteria. Comprehensive clinical evaluations and laboratory investigations will be recorded at baseline/admission. Patients will be followed up for [30 / 90 days] to assess clinical outcomes, including survival, recovery of renal function, or mortality. Multivariate statistical analysis will be applied to identify independent mortality predictors.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: mohamed emad salah, MBBCh
- Telefonnummer: +201005127591
- E-mail: muhamed.emad19@icloud.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Adults aged ≥ 18 years.
- Hospitalized cirrhotic patients who develop AKI and mortality occurs within 30 days of the development of AKI
Exclusion Criteria:
- Patients younger than 18 years
- Patients with HIV infection.
- Patients with previous liver transplantation.
- Patients with incomplete clinical or laboratory data
- Patients with end-stage chronic kidney disease on maintenance dialysis.
- Patients with acute liver failure without underlying liver cirrhosis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Cirrhotic Patients
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Short-term mortality
Tidsramme: From hospital admission up to hospital discharge, an average of 2 weeks
|
Mortality among cirrhotic patients presenting with acute kidney injury
|
From hospital admission up to hospital discharge, an average of 2 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum creatinine associated with in-hospital mortality
Tidsramme: From hospital admission up to hospital discharge, an average of 2 weeks
|
Serum creatinine will be assessed at hospital admission and its association with in-hospital mortality will be evaluated.
|
From hospital admission up to hospital discharge, an average of 2 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AKI in cirrhotic patients
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .