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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

I

Institute of Liver and Biliary Sciences, India

Status

Completed

Conditions

Ischemic Hepatitis

Treatments

Drug: Standard Care + NAC (N -ACETYLCYSTEINE)
Drug: Standard Care (in control arm)

Study type

Interventional

Funder types

Other

Identifiers

NCT02015403
ILBS-IH-01

Details and patient eligibility

About

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

Enrollment

220 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 2 patient groups

Standard Care + NAC (N-ACETYLCYSTEINE) infusion
Experimental group
Treatment:
Drug: Standard Care (in control arm)
Drug: Standard Care + NAC (N -ACETYLCYSTEINE)
Standard Care
Active Comparator group
Treatment:
Drug: Standard Care (in control arm)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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