Hepatocerebral EncephalopathyPhase 3NCT00553423
Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
A Phase 3 study testing Lactulose in people with Hepatocerebral Encephalopathy and Portal-Systemic Encephalopathy, run by Aga Khan University at 2 sites in Pakistan.
Trial summary
To evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy (HE) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy, Encephalopathy, Hepatic
- What is being tested?
- Lactulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesPakistan
- Study dates
- Nov 2007to Nov 2008
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- All acute gastrointestinal bleeding in cirrhotics without hepatic encephalopathy at the time of admission in ER
Who cannot join
- Increased α-fetoprotein level/ Documented hepatoma
- Portal or hepatic vein thrombosis
- Large-volume or tense ascites requiring repeated therapeutic paracentesis
- Serious recurrent or ongoing co morbid illness (e.g., severe renal, cardiac, or respiratory failure; sepsis)
- Pregnancy
- Not willing to give consent to participate in the study
- Patients who are unable to read and write
- ER arrival time > 12 hrs from index bleed
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Not yet recruiting
Aga Khan university
Karachi, Sindh, 74800
Shahid Majid, FCPS, 9221-4930051 ext. 4447, shahid.majid@aku.edu
Mohammad Salih, FCPS, 9221-4930051 ext. 4528, mohammad.salih@aku.edu
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Shahid Majid, FCPS, 9221-4930051 ext. 4447, shahid.majid@aku.edu
Mohammad Salih, FCPS, 9221-4930051 ext. 4528, mohammad.salih@aku.edu
About this study
Official title: Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
To evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy (HE) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients
Read the detailed description
Variceal hemorrhage occurs in 25 to 35 % of patients with cirrhosis and accounts for 80 to 90% of bleeding episodes in these patients. Around 25-30 percent of patients develop hepatic encephalopathy. Development of hepatic encephalopathy in patients with gastrointestinal bleed can cause increase morbidity with higher hospital costs in these patients. To date no randomized trial has been done in terms of prevention of encephalopathy in gastrointestinal hemorrhage. One trial has compared lactulose in combination with antibiotic against mannite, showed equal efficacy in both groups. No study has been done evaluate the efficacy of lactulose in prevention of encephalopathy in these patients.
We hypothesize that prophylactic use of Lactulose decreases the risk of development of hepatic encephalopathy with upper GI bleed in cirrhotics.
- Conditions
- Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy, Encephalopathy, Hepatic, Encephalopathy, Hepatocerebral
- Being tested
- Lactulose, Placebo
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
Lactulose 30 ml q6h for 48 hrs
PlaceboDrug
Placebo 30 ml q6hrly for 48 hrs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lactulose 30 ml q6h for 48 hrs Receives: Drug: Lactulose |
| 2 | Placebo comparator | Placebo 30 ml q6 hrly for 48hrs Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Clinically Overt Hepatic Encephalopathy
Measured: 48hours
Secondary outcomes (1)
Death, hospital stay
Measured: 48hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startNov 2007
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocerebral EncephalopathyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Shahid Majid, FCPS, Principal investigator, Aga Khan UniversityMohammad Salih, FCPS, Study director, Aga Khan UniversityShahid Ahmed, FCPS, Study director, Aga Khan UniversityWasim Jafri, FCPS, Study chair, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553423
- Sponsor's protocol ID
- 06GS013MED
- Status last verified
- Oct 2007
- First submitted
- 2 Nov 2007
- Last updated
- 5 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
- ClinicalTrials.gov ID
- NCT00553423
- Acronym / sponsor ID
- 06GS013MED
- Conditions
- Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy, Encephalopathy, Hepatic, Encephalopathy, Hepatocerebral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Study completion
- Nov 2008 (estimated)
- First posted
- 5 Nov 2007 (estimated)
- 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.
To evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy (HE) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients
Detailed description
Variceal hemorrhage occurs in 25 to 35 % of patients with cirrhosis and accounts for 80 to 90% of bleeding episodes in these patients. Around 25-30 percent of patients develop hepatic encephalopathy. Development of hepatic encephalopathy in patients with gastrointestinal bleed can cause increase morbidity with higher hospital costs in these patients. To date no randomized trial has been done in terms of prevention of encephalopathy in gastrointestinal hemorrhage. One trial has compared lactulose in combination with antibiotic against mannite, showed equal efficacy in both groups. No study has been done evaluate the efficacy of lactulose in prevention of encephalopathy in these patients.
We hypothesize that prophylactic use of Lactulose decreases the risk of development of hepatic encephalopathy with upper GI bleed in cirrhotics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LactuloseLactulose 30 ml q6h for 48 hrs |
| 2 | Placebo comparator | Drug: PlaceboPlacebo 30 ml q6 hrly for 48hrs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years
- All acute gastrointestinal bleeding in cirrhotics without hepatic encephalopathy at the time of admission in ER
Key exclusion criteria (8 listed)
- Increased α-fetoprotein level/ Documented hepatoma
- Portal or hepatic vein thrombosis
- Large-volume or tense ascites requiring repeated therapeutic paracentesis
- Serious recurrent or ongoing co morbid illness (e.g., severe renal, cardiac, or respiratory failure; sepsis)
- Pregnancy
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 |
|---|---|---|
| LactuloseLactulose 30 ml q6h for 48 hrs | Drug | 1 |
| PlaceboPlacebo 30 ml q6hrly for 48 hrs | Drug | 2 |
Primary outcome
Development of Clinically Overt Hepatic Encephalopathy
Time frame: 48hours
1 secondary outcome
Death, hospital stay
Time frame: 48hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2007.
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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.
Shahid Majid, FCPS principal investigator
Aga Khan University
Mohammad Salih, FCPS study director
Aga Khan University
Shahid Ahmed, FCPS study director
Aga Khan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactulose in people with Hepatocerebral Encephalopathy and Portal-Systemic Encephalopathy, run by Aga Khan University at 2 sites in Pakistan.
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 2 inclusion and 8 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 5 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shahid Majid, FCPS (9221-4930051 ext. 4447, shahid.majid@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Clinically Overt Hepatic Encephalopathy (time frame: 48hours). 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 5 Nov 2007.