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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).
This is a randomized control trial with the following objectives
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactulose AND LOLA | Experimental | Lactulose which is the standard of care treatment will be administered with the experimental drug L-ornithine L-aspartate (LOLA). |
|
| Lactulose and PEG | Experimental | Lactulose which is the standard of care treatment will be administered with the experimental drug polyethylene glycol (PEG). |
|
| Lactulose | Active Comparator | This group will receive Lactulose only which is the standard of care treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycols | Drug | 280g/ 24 hours for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient recovery among all groups through a change in mental state. | Change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome. | Change will be assessed at enrollment. |
| Patient recovery among all groups through a change in mental state. | A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome. | Change will be assessed at 24 hours post enrollment. |
| Patient recovery among all groups through a change in mental state. | A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome. | A change will be assessed at 48 hours post enrollment. |
| Patient recovery among all groups through a change in mental state. | A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome. | A change will be assessed at 72 hours post enrollment. |
| Patient recovery among all groups through a change in mental state. | A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome. | A change will be assessed at 96 hours post enrollment. |
| Patient recovery among all groups through a change in mental state. |
| Measure | Description | Time Frame |
|---|---|---|
| A change in Quality of Life will be assessed through SF-36 | A change in the quality of life will be assessed using a validated Urdu translation of the Rand Short Form 36 item survey (SF-36 U). The lower the score the more disability. The higher the score the less disability | Quality of life will be assessed at 28th day post enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zeeshan Ali, FCPS | Contact | +923211000393 | dr.zeeshan.j@gmail.com | |
| Shamim Kausar, FCPS | Contact | +923343093627 | drshamimahsan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bolan Medical Complex Hospital | Quetta | Balochistan | Pakistan |
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participants' attendants will also be masked and will give consent for the study in case the participant is admitted to the Intensive care unit and is not mentally stable to give consent.
| Lactulose oral solution |
| Drug |
60-120 ml per day for 5 days |
|
| L-ornithine L-aspartate | Drug | 30g/24 hours in 3 divided doses for 5 days |
|
A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome. |
| A change will be assessed at 120 hours post enrollment. |
| Patient recovery among all groups through a change in mental state. | A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome. | A change will be assessed at 144 hours post enrollment. |
| A change in Quality of Life will be assessed through SF-36 |
A change in the quality of life will be assessed using a validated Urdu translation of the Rand Short Form 36 item survey (SF-36 U).The lower the score the more disability. The higher the score the less disability |
| Quality of life will be assessed at 84th day post enrollment. |
| A change in mortality rate | It will be observed through weekly calls and monthly visits. | it will be inquired at 7th day post enrollment. |
| A change in mortality rate | It will be observed through weekly calls and monthly visits. | it will be inquired at 28th day post enrollment. |
| A change in mortality rate | It will be observed through weekly calls and monthly visits. | it will be inquired at 84th day post enrollment. |
| 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 | 71550 | Pakistan |
| CMC hospital | Larkana | Sindh | Pakistan |
|
| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D007792 | Lactulose |
| C002939 | ornithylaspartate |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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