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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03456518
Other study ID # POACLIFWHCV LC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date November 30, 2019

Study information

Verified date January 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The concept of acute-on-chronic liver failure (ACLF) was introduced by Jalan and Williams in 2002 to describe the acute deterioration in liver function over 2 to 4 weeks in a patient with well-compensated cirrhosis associated with a precipitating event (hepatotoxic: superimposed hepatitis viral infection, drug-induced liver injury, hepatotoxins, or excessive alcohol consumption; extra hepatic: variceal bleeding or sepsis), leading to severe deterioration in clinical status with jaundice and hepatic encephalopathy and/or HRS. Following this concept, several proposals for the diagnostic criteria of ACLF have been suggested.


Description:

There may be regional differences in etiology, pathogenesis, and natural course of ACLF, which may in turn influence the overall outcome of this syndrome. So, proper diagnosis of ACLF and its precipitating factors in our locality enable us for proper management of these cases and dealing with these precipitating factors to be avoided later on in patients with liver cirrhosis

Aim of the work:

To identify the pattern of acute on chronic liver cell failure (ACLF) within 28 days including prevalence, percipitating factors, and outcome.

Patients and methods

Type of the study: Prospective hospital based study

Site of the study: Tropical Medicine and Gastroenterology Department, Al-Rajhi University Hospital, Assiut University Hospitals, Assiut, Egypt. Written consent will be obtained from all the participants or their relatives before enrollment.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 30, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult Patients with HCV related CLD based on clinical, biochemical and imaging evidence., with or without prior decompensation.

- Patients diagnosed to have ACLIF at any grade (1-3)

Exclusion Criteria:

- Acute liver failure without evidence of chronic liver disease.

- Other etiology of chronic liver disease

- Patients diagnosed with no ACLIF No ACLF

- This category includes patients who either:

- Do not have any organ failure

- Have a single organ failure that does not involve the kidney with a serum creatinine level of <1.5 mg per dl and no hepatic encephalopathy

- Have a single brain failure with a serum creatinine level of <1.5 mg per dl

- Patients refuse to participate.

Study Design


Locations

Country Name City State
Egypt Al-Rajhi liver hospital ,Assiut university Assiut
Egypt Al-Rajhi Liver Hospital, Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Ginés P, Quintero E, Arroyo V, Terés J, Bruguera M, Rimola A, Caballería J, Rodés J, Rozman C. Compensated cirrhosis: natural history and prognostic factors. Hepatology. 1987 Jan-Feb;7(1):122-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pattern of acute on chronic liver cell failure evaluation of cases with acute on chronic liver cell failure as number of cases diagnosed with ACLF in this period , the precipitating factor of the condition , the fate of the patient (improving or deterioration or death ) in the 28 days following diagnosis . march 2018 to march 2019
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