Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05920213
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-13
First Post:
2023-06-16
Brief Title:
Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy
Sponsor:
Jinnah Postgraduate Medical Centre
Organization:
Jinnah Postgraduate Medical Centre
Study Overview
Official Title:
HELP Trial Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
Participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to the patients 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 participants 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
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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None