To Compare The Efficacy Of N -Acetylcysteine and Standard Therapy Versus Standard Therapy In The Prevention Of Ischemic Hepatitis And Survival Post Upper GI Bleed

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

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-05-31

Brief Summary

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

Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences) emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care Unit) in view of upper GI bleed randomized to two groups

GROUP A : 110 Patients will receive standard care + NAC infusion for 72 hours

GROUP B : 110 Patients will receive standard care only

NAC will be given at following rate :

Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then continuous infusion of 6.25 mg/kg for the remaining 67 hrs

Related Clinical Trials

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

To Compare a Hemostatic Powder TC-325 and Standard Treatment in the Control of Acute Upper Gastrointestinal Bleeding From Nonvariceal Causes

NCT02534571

Acute Upper Gastrointestinal Bleeding

COMPLETED PHASE3

Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients

NCT01292915

Re-bleeding in NVUGIB

COMPLETED

Rifaximin in Patients With Gastroesophageal Variceal Bleeding

NCT02991612

Cirrhosis Esophageal and Gastric Varices Gastrointestinal Hemorrhage

COMPLETED NA

Secondary Prophylaxis Gastric Variceal Bleed

NCT00888784

Cirrhosis

COMPLETED NA

Efficacy of a Novel Hemostatic Powder in GI Bleeding

NCT02595853

Gastrointestinal Bleeding

COMPLETED

Detailed Description

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

Conditions

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

Ischemic Hepatitis

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.

Standard Care + NAC (N-ACETYLCYSTEINE) infusion

Group Type EXPERIMENTAL

Standard Care + NAC (N -ACETYLCYSTEINE)

Intervention Type DRUG

Standard Care (in control arm)

Intervention Type DRUG

Standard Care

Group Type ACTIVE_COMPARATOR

Standard Care (in control arm)

Intervention Type DRUG

Interventions

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

Standard Care + NAC (N -ACETYLCYSTEINE)

Intervention Type DRUG

Standard Care (in control arm)

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Age \> 18 and \< 75
* Cirrhotics with UGIE (Upper Gastrointestinal Endoscopy ) within last 24 hours.

Exclusion Criteria

* Non cirrhotic
* Hepatocellular carcinoma
* Advanced cardiopulmonary disease
* Pregnancy
* Extrahepatic malignancy
* Patient on anticoagulation therapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No