CirrhosisNCT03448770
To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.
A study testing PEG- 17 gm sachet and Lactulose : 20-30gm in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- PEG- 17 gm sachet and Lactulose : 20-30gm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented cirrhosis with any underlying etiology
- Hepatic encephalopathy of grade II and above
- 18 to 65 years of age
Who cannot join
- Acute change in mental status due to a diagnosis other than hepatic encephalopathy
- Patients who have received lactulose as an anticoma measure before enrollment
- Patient who have developed encephalopathy post bleed
- Patients with gut paralysis
- Patients with tense ascites
- Patients with altered sensorium due to organic brain disease.
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- Patients with coexistent psychiatric illness that may hamper the proper assessment of hepatic encephalopathy
- Hemodynamic instability obviating vasopressors for resuscitation
- 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
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Abhinav Verma, MD, 01146300000, abhinav.3183@gmail.com
Dr Abhinav Verma, MD
About this study
Official title: To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics: A Randomized Controlled Trial
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.
- Conditions
- Cirrhosis
- Being tested
- PEG- 17 gm sachet, Lactulose : 20-30gm
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG- 17 gm sachetDrug
PEG- 17 gm sachet 3-4 times per day
Lactulose : 20-30gmDrug
Lactulose : 20-30gm
| Study group | Role | What they receive |
|---|---|---|
| Lactulsoe | Active comparator | Lactulose : 20-30gm 2-3 doses per day Receives: Drug: Lactulose : 20-30gm |
| Polyethlene Glycol | Experimental | PEG (Polyethlene Glycol)- 17 gm sachet 3-4 times per day Receives: Drug: PEG- 17 gm sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete reversal of hepatic encephalopathy in both groups.
Complete reversal is defined as Grade 0 Encephalopathy
Measured: 3 days
Secondary outcomes (4)
Improvement in hepatic encephalopathy by two grades in both groups
Measured: 3 days
Length of Intensive Care Unit stay in both groups
Measured: 28 days
Adverse events in both groups
Measured: 3 days
Presence of encephalopathy changes in Electroencephalography in both groups
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Aug 2017
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448770
- Sponsor's protocol ID
- ILBS-cirrhosis-14
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03448770
- Acronym / sponsor ID
- ILBS-cirrhosis-14
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulsoe | Active comparator | Drug: Lactulose : 20-30gmLactulose : 20-30gm 2-3 doses per day |
| Polyethlene Glycol | Experimental | Drug: PEG- 17 gm sachetPEG (Polyethlene Glycol)- 17 gm sachet 3-4 times per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented cirrhosis with any underlying etiology
- Hepatic encephalopathy of grade II and above
- 18 to 65 years of age
Key exclusion criteria (10 listed)
- Acute change in mental status due to a diagnosis other than hepatic encephalopathy
- Patients who have received lactulose as an anticoma measure before enrollment
- Patient who have developed encephalopathy post bleed
- Patients with gut paralysis
- Patients with tense ascites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG- 17 gm sachetPEG- 17 gm sachet 3-4 times per day | Drug | Polyethlene Glycol |
| Lactulose : 20-30gmLactulose : 20-30gm | Drug | Lactulsoe |
Primary outcome
Complete reversal of hepatic encephalopathy in both groups.
Time frame: 3 days
Complete reversal is defined as Grade 0 Encephalopathy
4 secondary outcomes
Improvement in hepatic encephalopathy by two grades in both groups
Time frame: 3 days
Length of Intensive Care Unit stay in both groups
Time frame: 28 days
Adverse events in both groups
Time frame: 3 days
Presence of encephalopathy changes in Electroencephalography in both groups
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG- 17 gm sachet and Lactulose : 20-30gm in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Abhinav Verma, MD (01146300000, abhinav.3183@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete reversal of hepatic encephalopathy in both groups. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.