Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy
NCT ID: NCT05920213
Last Updated: 2023-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
360 participants
INTERVENTIONAL
2023-10-31
2024-04-30
Brief Summary
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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).
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Lactulose AND LOLA
Lactulose which is the standard of care treatment will be administered with the experimental drug L-ornithine L-aspartate (LOLA).
Lactulose oral solution
60-120 ml per day for 5 days
L-ornithine L-aspartate
30g/24 hours in 3 divided doses for 5 days
Lactulose and PEG
Lactulose which is the standard of care treatment will be administered with the experimental drug polyethylene glycol (PEG).
Polyethylene Glycols
280g/ 24 hours for 5 days
Lactulose oral solution
60-120 ml per day for 5 days
Lactulose
This group will receive Lactulose only which is the standard of care treatment.
Lactulose oral solution
60-120 ml per day for 5 days
Interventions
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Polyethylene Glycols
280g/ 24 hours for 5 days
Lactulose oral solution
60-120 ml per day for 5 days
L-ornithine L-aspartate
30g/24 hours in 3 divided doses for 5 days
Eligibility Criteria
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Inclusion Criteria
* diagnosed on clinical/ultrasound findings with HE (grade 2 or above) with or without precipitating factors.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Jinnah Postgraduate Medical Centre
OTHER_GOV
Responsible Party
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ZA
Associate professor
Locations
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Bolan Medical Complex Hospital
Quetta, Balochistan, Pakistan
Sheikh Khalifa bin Zayed
Quetta, Balochistan, Pakistan
Nishtar Medical Univeristy and Hospital
Multan, Punjab Province, Pakistan
Sheikh Zayed Medical College/Hospital
Rahim Yar Khan, Punjab Province, Pakistan
Medical ICU, Jinnah Postgraduate Medical Centre
Karachi, Sindh, Pakistan
CMC hospital
Larkana, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JSMU/IRB/2022/673
Identifier Type: -
Identifier Source: org_study_id
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