Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-05

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

SIRS in ACLF exacerbate adverse effects of ammonia - sarcopenia, infections, immune dysfunction, HE and organ dysfunction Persistent or incident hyperammonemia during first week of hospitalization in patients with ACLF is associated with increased risk of organ failure and death. Prospective studies on the efficacy of ammonia lowering therapies on major adverse liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) in hyperammonemic ACLF patients with no overt HE are limited. In this study we aim to to compare the safety and efficacy of ammonia lowering therapy (goal directed lactulose and rifaximin) compared to SMT to prevent major liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) in hyperammonemic ACLF patients with no overt HE.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy.

NCT02321371

Acute-On-Chronic Liver Failure

COMPLETED NA

SALT for Treatment of Patients With Early ACLF

NCT06069037

Acute-On-Chronic Liver Failure

NOT_YET_RECRUITING NA

To Study the Clinical Course and Outcomes of Non-electively Hospitalised Patients of Chronic Liver Disease (CLD) With Hepatic or Extra-hepatic Predominant Organ Failure(s) at 6 Months.

NCT07270809

Chronic Liver Disease

NOT_YET_RECRUITING

Rifaximin Versus Lactulose in Renal Failure

NCT00748904

Liver Cirrhosis Renal Failure

WITHDRAWN PHASE4

High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure

NCT02718079

Acute Liver Failure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hypothesis: Goal directed ammonia lowering therapy in hyperammonemic ACLF patients with no overt HE leads to reduced incidence of major adverse liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) at day 7, 28 and day 90.

AIM:- To compare the safety and efficacy of ammonia lowering therapy (goal directed lactulose and rifaximin) compared to SMT to prevent major liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) in hyperammonemic ACLF patients with no overt HE.

Study design:

* A Prospective Randomized Controlled Trial.
* Single Centre.
* Open label.
* Block Randomization will be done , it will be implemented by IWRS method.
* The study will be conducted in Department of Hepatology, ILBS.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute on Chronic Liver Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

lactulose and rifaximin

T. Rifaximin 550 mg po bd Syp Lactulose to ensure 2-3 motions

Group Type EXPERIMENTAL

Lactulose

Intervention Type DRUG

Syp lactulose

Rifaximin

Intervention Type DRUG

Rifaximin

Standard Medical Treatment

Routine medicines, Albumin Iv antibiotics,Protein powder , branched chain amino acids

Group Type ACTIVE_COMPARATOR

Standard Medical treatment

Intervention Type OTHER

Standard Medical treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactulose

Syp lactulose

Intervention Type DRUG

Rifaximin

Intervention Type DRUG

Standard Medical treatment

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18-70 years
2. ACLF as per APASL criteria (AARC grade I/II)
3. Baseline ammonia levels of ≥135ug/dl or 79.5umol/l
4. Given informed consent

Exclusion Criteria

* 1\. Overt HE 2. AARC grade III 3. Confirmed or suspected bacterial infection 4. Extrahepatic organ failure 5. Renal dysfunction lasting for more than 48 hours or need for vasoconstrictors 6. Paralytic ileus 7. Patients with hepatocellular carcinoma beyond Milan criteria or any other neoplastic disorder 8. Pregnant and lactating women 9. Use of lactulose, rifaximin or LOLA in past 48h 10. Uncontrolled DM, HT, CAD 11. Patients with allergy or other contraindications of the used drugs

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No