Our purpose is to assess the effect of Polyethylene Glycol (PEG) together with lactulose versus lactulose alone in the treatment of patients with hepatic encephalopathy. This mono-center trial will be performed in Shariati hospital, Tehran province, Iran and in 2, 24-patient groups and in a single-blind setting. Patients are randomly assigned to different treatment groups according to a block randomization number list. All patients with a known history of documented cirrhosis who had hepatic encephalopathy were eligible to participate in this trial regarding to inclusion criteria (age between 18 to 80, presence of cirrhosis and encephalopathy and sign of informed consent form) and exclusion criteria (acute liver failure, other causes of altered mental status, lack of agreement, hemodynamic instability and pregnancy). Lactulose group receive lactulose in a specific dose, orally or by enema. Polyethylene Glycol (PEG) – lactulose group, receive PEG solution additional to standard treatment that lactulose group received. Serial physical examinations will be performed by a team member; at beginning presentation and 24 hours later along with some clinical variables (CPT scoring system and MELD scoring system to assess severity of cirrhosis) and baseline laboratory test to assess the complete randomization between 2 groups. Along with physical examination, clinical variables and baseline laboratory tests, we’ll also check the baseline and after-treatment level of blood level of ammonia as a probable severity indicator for hepatic encephalopathy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015083117719N2
Registration date:2015-10-02, 1394/07/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-02, 1394/07/10
Registrant information
Name
Amir Ali Sohrabpour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 82414000
Email address
aasohrabpour@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Office for connection between industry, university and community, Tehran University of Medical Sciences
Expected recruitment start date
2015-09-10, 1394/06/19
Expected recruitment end date
2015-10-11, 1394/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
PEG-Lactulose versus lactulose in the treatment of hepatic encephalopathy in cirrhotic patients in Shariati hospital.
Public title
The effect of PEG in the treatment of hepatic encephalopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 to 80 years old; Documented cirrhosis with any underlying etiology; Any grade of hepatic encephalopathy; Signed informed consent by patient or his/her LARs (if there is an imperfect level of consciousness)
Exclusion criteria: Acute liver failure that was defined as the onset of severe acute liver injury with encephalopathy and international normalized ratio (INR) of ≥1.5 in a patient without cirrhosis or preexisting liver disease; Altered mental status due to a diagnosis other than hepatic encephalopathy; Patient's or his/her LAR unwillingness to this trial; Hemodynamic instability which needs vasopressors for resuscitation; Pregnancy.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences, Shariati Hospital
Street address
Shariati Hospital, Ale Ahmad Exp.way, Tehran
City
Tehran
Postal code
Approval date
2015-03-01, 1393/12/10
Ethics committee reference number
416/984
Health conditions studied
1
Description of health condition studied
Cirrhosis
ICD-10 code
K74.6
ICD-10 code description
Other and unspecified cirrhosis of liver
Primary outcomes
1
Description
Severity of hepatic encephalopathy
Timepoint
At presentation and 24 h later
Method of measurement
HESA (Hepatic Encephalopathy Scoring Algorithm)
Secondary outcomes
1
Description
Blood level of ammonia
Timepoint
At presentation and 24 h later
Method of measurement
Blood sampling
Intervention groups
1
Description
Lactulose group (control group) will receive either 20 to 30 grams of lactulose (at least 3 doses in 24 hours) orally or by a nasogastric tube, or 200 grams of lactulose enema by a rectal tube for 24 hours.
Category
Treatment - Drugs
2
Description
Polyethylene Glycol (PEG) – lactulose group (intervention group), will receive a single dose of 4 liters of PEG solution contain PEG in an amount of 280 grams additional to standard treatment that lactulose group received (Lactulose group (control group) will receive either 20 to 30 grams of lactulose (at least 3 doses in 24 hours) orally or by a nasogastric tube, or 200 grams of lactulose enema by a rectal tube for 24 hours.).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr Amir Ali Sohrabpour
Street address
Shariati hospital, Ale Ahmad Exp Way, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences-Collaborative Office Between University,Industry and Society
Full name of responsible person
Ms Shamila Nazhati
Street address
Central Building of Tehran University of Medical Sciences, Ghods St. , Keshavarz Blvd. , Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences-Collaborative Office Between University,Industry and Society
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Naderian
Position
MD Student
Other areas of specialty/work
Street address
Enqelab Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 912 245 4909
Fax
Email
naderian.mr@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Ali Sohrabpour
Position
Internist
Other areas of specialty/work
Street address
Dr Shariati Hospital, Ale Ahmad Exp.way
City
Tehran
Postal code
Phone
+98 912 159 8994
Fax
Email
aasohrabpour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Ali Sohrabpour
Position
Internist, An Academic Staff
Other areas of specialty/work
Street address
Shariati Hospital, Ale Ahmad Exp.Way
City
Tehran
Postal code
1411713135
Phone
+98 21 8241 4000
Fax
+98 21 8241 5400
Email
aasohrabpour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)