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IRCT2015083117719N2 IRCT 2015-10-02 Tehran University of Medical Sciences-Collaborative Office Between University,Industry and Society The effect of PEG in the treatment of hepatic encephalopathy PEG-Lactulose versus lactulose in the treatment of hepatic encephalopathy in cirrhotic patients in Shariati hospital. 2015-09-10 anticipated 48 Complete https://irct.ir/trial/16212 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Cirrhosis. Intervention 1: 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. Intervention 2: 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.).
public Mohammadreza Naderian
Enqelab Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 912 245 4909 naderian.mr@gmail.com Tehran University of Medical Sciences scientific Amir Ali Sohrabpour
Dr Shariati Hospital, Ale Ahmad Exp.way
Tehran Iran (Islamic Republic of) +98 912 159 8994 aasohrabpour@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 80 years Both K74.6 Other and unspecified cirrhosis of liver Treatment - Drugs Treatment - Drugs 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. 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.). Severity of hepatic encephalopathy. Timepoint: At presentation and 24 h later. Method of measurement: HESA (Hepatic Encephalopathy Scoring Algorithm). Blood level of ammonia. Timepoint: At presentation and 24 h later. Method of measurement: Blood sampling. Tehran University of Medical Sciences-Collaborative Office Between University,Industry and Society Approved 2015-03-01 Tehran University of Medical Sciences, Shariati Hospital Shariati Hospital, Ale Ahmad Exp.way, Tehran Tehran Iran (Islamic Republic of)