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To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.

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ClinicalTrials.gov Identifier: NCT03448770
Recruitment Status : Unknown
Verified February 2018 by Institute of Liver and Biliary Sciences, India.
Recruitment status was:  Recruiting
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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Brief Summary:
All patients presenting to the emergency department of Institute of Liver and Biliary Sciences with known cirrhosis and hepatic encephalopathy with grade II will be included in the study. The patient will be randomized into one of the two arms of lactulose or polyethylene glycol. The patient on the lactulose arm will be administered 20 to 30 g of lactulose orally or by nasogastric tube (3 or more doses within 24 hours ) or if oral intake was not possible or inadequate. The Dose will be repeated to ensure 3-4 loose motions per day. The Polyethylene Glycol group will get 17 gm of PEG (Polyethylene Glycol) administered orally or via nasogastric tube. PEG (Polyethylene Glycol)will be administered in 3-4 doses in 24 hours to ensure 3-4 loose stools per day.

Condition or disease Intervention/treatment Phase
Cirrhosis Drug: PEG- 17 gm sachet Drug: Lactulose : 20-30gm Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics: A Randomized Controlled Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Lactulose

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lactulsoe
Lactulose : 20-30gm 2-3 doses per day
 Drug: Lactulose : 20-30gm
Lactulose : 20-30gm
Experimental: Polyethlene Glycol
PEG (Polyethlene Glycol)- 17 gm sachet 3-4 times per day
 Drug: PEG- 17 gm sachet
PEG- 17 gm sachet 3-4 times per day


Outcome Measures
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Primary Outcome Measures :
  1. Complete reversal of hepatic encephalopathy in both groups. [ Time Frame: 3 days ]
    Complete reversal is defined as Grade 0 Encephalopathy


Secondary Outcome Measures :
  1. Improvement in hepatic encephalopathy by two grades in both groups [ Time Frame: 3 days ]
  2. Length of Intensive Care Unit stay in both groups [ Time Frame: 28 days ]
  3. Adverse events in both groups [ Time Frame: 3 days ]
  4. Presence of encephalopathy changes in Electroencephalography in both groups [ Time Frame: 3 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Documented cirrhosis with any underlying etiology
  2. Hepatic encephalopathy of grade II and above
  3. 18 to 65 years of age

Exclusion Criteria:

  1. Acute change in mental status due to a diagnosis other than hepatic encephalopathy
  2. Patients who have received lactulose as an anticoma measure before enrollment
  3. Patient who have developed encephalopathy post bleed
  4. Patients with gut paralysis
  5. Patients with tense ascites
  6. Patients with altered sensorium due to organic brain disease.
  7. Patients with coexistent psychiatric illness that may hamper the proper assessment of hepatic encephalopathy
  8. Hemodynamic instability obviating vasopressors for resuscitation
  9. Acute liver failure defined as severe acute liver injury with encephalopathy and international normalized ratio (INR)≥1.5 in a patient without pre-existing liver disease
  10. Refusal of consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448770


Contacts
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Contact: Dr Abhinav Verma, MD 01146300000 abhinav.3183@gmail.com

Locations
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India
Institute of liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Abhinav Verma, MD    01146300000    abhinav.3183@gmail.com   
Principal Investigator: Dr Abhinav Verma, MD         
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
More Information
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03448770    
Other Study ID Numbers: ILBS-cirrhosis-14
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
 Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Lactulose
Gastrointestinal Agents