Comparison of two laxatives, lactulose and polyethylene glycol, in early resolution of hepatic encephalopathy in children with acute liver failure.

Comparison Of Lactulose versus Polyethylene Glycol In Management Of Hepatic Encephalopathy In Pediatric Acute Liver Failure: A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093733

Enrollment

Registered

2025-08-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K720- Acute and subacute hepatic failure Health Condition 2: K729- Hepatic failure, unspecified

Interventions

Intervention1: POLYETHYLENE GLYCOL ORAL SOLUTION: Initial 1g per kg first dose, followed by 0.5g per kg every 12 hourly Titration 0.25 g per kg per dose (maximum 100g per day) Dose Titration: 0.5 mL p

Eligibility

Inclusion criteria

Inclusion criteria: Children with signs and symptoms of liver dysfunction fulfilling all the following criteria will be included: 1. Age: 1 month - 18 years 2. INR more than or equal to 1.5 (without vitamin K deficiency) 3. Evidence of hepatic encephalopathy (any grade) 4. Acute onset liver dysfunction (<8 weeks) 5. Written informed consent from parent/guardian 6. Assent when age-appropriate

Exclusion criteria

Exclusion criteria: Children fulfilling the inclusion criteria but having any of the following will be excluded: o Known chronic liver disease o Prior neurological disorders affecting HE assessment

Design outcomes

Primary

Measure	Time frame
Time to improvement defined as: Decrease by at least one grade on West Haven Criteria OR PALFSG Criteria o Measured from first dose administration o Improvement must be sustained for AT LEAST 12 hours o Assessment by blinded evaluator (DM Pediatric Gastroenterology trainee in the study department, not directly involved in the trial)Timepoint: at admission, and then at every 8 hour interval from admission till decrease in hepatic encephalopathy by 1 grade is noted.	—

Measure

Time frame

Time to improvement defined as: Decrease by at least one grade on West Haven Criteria OR PALFSG Criteria o Measured from first dose administration o Improvement must be sustained for AT LEAST 12 hours o Assessment by blinded evaluator (DM Pediatric Gastroenterology trainee in the study department, not directly involved in the trial)Timepoint: at admission, and then at every 8 hour interval from admission till decrease in hepatic encephalopathy by 1 grade is noted.

—

Secondary

Measure	Time frame
TIME TO COMPLETE RESOLUTION OF HEPATIC ENCEPHALOPATHYTimepoint: 24 HOURS, 48 HOURS AND 72 HOURS SINCE ADMISSION;NEED FOR MECHANICAL VENTILATIONTimepoint: DISCHARGE OR DEATH;NEED AND LENGTH OF PICU STAYTimepoint: DISCHARGE OR DEATH;DURATION OF HOSPITAL STAYTimepoint: DISCHARGE OR DEATH;28 DAY SURVIVAL STATUS AND LIVER FUNCTIONTimepoint: 28 DAYS POST DISCHARGE	—

Countries

India

Contacts

Public ContactDibyendu Sekhar Das

AIIMS Rishikesh

drnmbhat@gmail.com9412051110

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026