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CTRI Number  CTRI/2024/08/072222 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of dialysis in liver disease patients presented with decreased consciousness 
Scientific Title of Study   Impact of Sustained Low Efficiency Dialysis with Standard Medical Therapy versus Standard Medical Therapy alone in the Management of Patients with Chronic Liver Disease, Hyperammonemia and Hepatic Encephalopathy: A Randomized Comparative Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Jhajharia 
Designation  Associate Professor  
Affiliation  SMS Medical College & Hospital 
Address  Department of Gastroenterology Room No. 313, IIIrd Floor SMS Superspeciality Hospital, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  09414236572  
Fax    
Email  drashokjhajharia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashank Singh 
Designation  Senior Resident 
Affiliation  SMS Medical College & Hospital 
Address  Department of Gastroenterology Room No. 313, IIIrd Floor, SMS Superspeciality Hospital, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  08900921209  
Fax    
Email  shashank05gwalior@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Jhajharia 
Designation  Associate Professor  
Affiliation  SMS Medical College & Hospital 
Address  Department of Gastroenterology Room No. 313, IIIrd Floor SMS Superspeciality Hospital, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  09414236572  
Fax    
Email  drashokjhajharia@gmail.com  
 
Source of Monetary or Material Support  
SMS Medical College & Hospital Jaipur Rajasthan Pin 302004 India 
 
Primary Sponsor  
Name  MMCBSY Scheme Govt of Rajasthan 
Address  Department of Gastroenterology Room No. 313, IIIrd Floor, SMS Superspeciality Hospital, Jaipur, Rajasthan, India Pincode 302004 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashok Jhajharia   SMS Medical College Jaipur  Department of Gastroenterology, Room No. 313, IIIrd Floor, SMS Superspeciality Hospital, Jaipur Jaipur RAJASTHAN Jaipur RAJASTHAN
Jaipur
RAJASTHAN 		 9414236572

drashokjhajharia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
office of ethics committee sms medical college jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K703||Alcoholic cirrhosis of liver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Medical Therapy (SMT)   In the Standard Medical Therapy (SMT) group, participants will be treated with medications like lactulose and rifaximin (550 mg twice daily), along with other necessary treatments based on established treatment guidelines. This may include antibiotics, vasopressors, ventilatory support, or treatments for bleeding. These treatments will continue until there is an improvement of at least two grades in HE (West Haven), their serum ammonia level drops below 40 umol/L, or until the fifth day of their hospital stay. 
Intervention  sustained low-efficiency dialysis (SLED) with standard medical therapy (SMT)  In the intervention group (SLED plus SMT), participants will have repeated SLED sessions every 48 hours, along with the previously mentioned SMT. This treatment will continue until their HE (West Haven) improves by at least two grades from the baseline or their serum ammonia levels drop below 40 umol/L. Throughout the study, serum biochemical parameters, clinical symptoms, and signs will be regularly checked and recorded at the start, before and after each SLED session, and daily until the fifth day of hospitalization. Under a Nephrologists supervision, SLED sessions will use either internal jugular or femoral access, lasting 6 hours with the following settings: dialysate flow rate at 200 ml/min, blood flow rate at 100 ml/min, bicarbonate-based dialysate, and no heparin. Vital signs will be checked hourly. Participants will be closely watched for any adverse events, such as low blood pressure, bleeding issues, allergic reactions, etc., and will receive appropriate treatment if needed. If any life-threatening issues occur, further SLED sessions will be stopped 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients who are between 18 and 60 years old and have decompensated chronic liver disease, diagnosed through biochemical, radiological, and endoscopic tests, can participate. They must also have overt hepatic encephalopathy, classified by the West Haven system and HESA, and a serum ammonia level higher than 100 micromoles per liter. Additionally, they need to be able to understand and agree to sign a written informed consent form, either by themselves or through their caregivers. 
 
ExclusionCriteria 
Details  This study will not include pregnant or breastfeeding women, patients younger than 18 years or older than 60 years, and those who cannot secure adequate vascular access for dialysis. Patients with unstable blood pressure that cannot be managed with medication, those with uncontrolled bleeding disorders or coagulopathy even after treatment, those with active infections or sepsis, and those who refuse or cannot tolerate the procedure will also be excluded 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The main outcome is to evaluate the change in serum ammonia levels in each group after the intervention.  baseline, 48 hours, 96 hours, 3months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 

The secondary outcomes of the study are to evaluate the effects of sustained low-efficiency dialysis combined with standard medical therapy on several parameters during the hospital stay. These parameters include changes in hepatic encephalopathy grading according to West Haven and HESA, the number of dialysis sessions, serum lactate and sodium levels, the duration of organ support needs such as ventilation and vasopressors, and changes in serum profiles including INR, bilirubin, albumin, creatinine, potassium, phosphate, and pH. Additionally, the study will assess the feasibility of this treatment approach by monitoring the number of blood transfusions needed, the occurrence of adverse events like coagulopathy, hypotension, and mortality, the need for upgrading antibiotics, study retention and compliance rates, and the average survival time up to three months after hospitalization. 		 Baseline and after each dialysis treatment and up to fifth day after hospitalisation 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   25/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drashokjhajharia@gmail.com].

  6. For how long will this data be available start date provided 29-08-2025 and end date provided 29-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Chronic liver disease primarily affects liver cells, leading to impaired ammonia metabolism and resulting in hyperammonemia, which can cause hepatic encephalopathy, cerebral edema, and intracranial hypertension. The exact mechanisms of hepatic encephalopathy are not fully understood, but factors in the blood, such as inflammation, oxidative stress, lactate, and bile acids, play significant roles. Current treatments for hepatic encephalopathy include ammonia-reducing agents like lactulose and rifaximin, and sometimes L-ornithine-L-aspartate for refractory cases. Extracorporeal devices may also help reduce ammonia and other inflammatory markers. Renal replacement therapy (RRT) is used in cirrhotic patients with acute kidney injury or hepatorenal syndrome to manage fluid balance, electrolytes, and solute clearance. However, there are no comparative studies on different RRT modalities for hyperammonemia or hepatic encephalopathy in chronic liver disease patients. This study aims to compare the effectiveness and feasibility of adding sustained low-efficiency dialysis to standard medical therapy versus standard medical therapy alone. 
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