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ClinicalTrials.gov ID

NCT05920213

Lead Sponsor

Jinnah Postgraduate Medical CentreOTHER_GOV

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

360Estimated

Last Update Posted

Jul 13, 2023Actual

Start Date

Oct 2023Estimated

Primary Completion Date

Apr 2024Estimated

Completion Date

Apr 2024Estimated

Official Title

HELP Trial: Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy

Brief Summary

The goal of this clinical trial is to compare the efficacy of L-ornithine L-aspartate and Polyethylene Glycol in Cirrhotic Patients with Overt Hepatic Encephalopathy.

Participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to the patient's health. Treatments that they will receive after inclusion in the study, will be the standard treatment (Lactulose) along with additional medication as part of our research (LOLA or Polyethylene glycol).

Detailed Description

This is a randomized control trial with the following objectives

• what is the efficacy of add-on LOLA therapy in patients of overt HE (Grade II and above) against the standard-of-care arm
• what is the efficacy of adding on polyethylene glycol (PEG) in overt HE (Grade II and above) against the standard-of-care arm

Randomization will be done using card randomization. three different color-coded cards will be kept. Any card will be randomly picked for the patient fulfilling inclusion criteria and will be treated according to the allocated treatment arm mentioned on the card

Patients will be diagnosed on the basis of Modified West Haven Criteria. For diagnosis and prognosis, the following tools will be used:

• Modified West Haven criteria and Glasgow coma scale will be used to assess the mental state.
• CLIF-C ADs and CLIF SOFA score will be used as a prognostic score for predicting mortality in hospitalized patients.
• Overt HE patients will be graded using the Hepatic encephalopathy grading instrument (HEGI).
• Child-Pugh classification and MELD scoring will be used to assess the severity of chronic liver disease and cirrhosis.

Written informed consent will be obtained from the immediate attendant of the patient. All ethical considerations will be followed.

Our research has been approved by Jinnah Sindh Medical University, Karachi. For this approval, the investigators have made every effort to ensure the confidentiality of research data collected from all our participants in this survey. The information collected will be stored with the investigators only in the form of de-identified information and will be retained in a secure place under lock and key. Any results that will be generated will be presented on a collective basis, and will not contain the participant's name or any other personal details.

Data entry and analysis will be done using SPSS Software version 23. Study analysis will be done using the principle of intention to treat. Primary and secondary outcomes will be studied among intervention and standard-of-care groups at a Confidence Interval of 95%. The chi-square test will be used to find the association of independent variables like age, gender, and HE grades with interventional therapies. Independent t-test will be used to compare mean scores between groups.

• Hepatic Encephalopathy Stage 2
• Hepatic Encephalopathy Stage 3
• Hepatic Encephalopathy Stage 4

• Polyethylene Glycols
• Lactulose oral solution
• L-ornithine L-aspartate

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Admitted cirrhotic patients above 18 years of age,
• diagnosed on clinical/ultrasound findings with HE (grade 2 or above) with or without precipitating factors.

Exclusion Criteria:

• Patients with hepatocellular carcinoma
• severe septicemia,
• active upper gastrointestinal bleeding and in a state of shock
• presence of underlying chronic renal failure (serum creatinine >1.5 mg/dl)
• presence of hepatorenal syndrome
• neurodegenerative disease
• patients with a head injury and drug intoxication
• acute superimposed liver injury
• advanced cardiac or pulmonary derangements
• end-stage renal disease
• pregnant or breastfeeding mothers
• patients who are on sedatives, antidepressants, or benzodiazepines

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Factorial Assignment

Masking

Single

Lead Sponsor

Jinnah Postgraduate Medical CentreOTHER_GOV

farhana_kayani@hotmail.com+92-3323113852

dralihyder75@yahoo.com+923334368045