Effect of Neostigmine (drug) in Critically ill Cirrhotics (liver disease).

Not Applicable

Conditions: Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Registration Number: CTRI/2024/06/068505

Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance.

2.Patients with new onset lower GI tract paralysis with clinical presentation of feed intolerance defined as GRV more than 500ml, abdominal distension, bowel distension on abdominal imaging, and absence of bowel sounds.

Exclusion Criteria

1.Recent GI bleed

2.Bronchoconstriction

3.Bradycardia

4.Current or past history of surgical abdomen, including mechanical obstruction, mesenteric ischemia, perforation or requiring abdominal surgery.

5.Prior comorbid illnesses like advanced cardiopulmonary disease, prior episodes of arrhythmia, structural heart diseases, traumatic brain injury, cerebrovascular accidents, raised intracranial pressures, history of myasthenia gravis.

6.Endocrinological illnesses like uncontrolled hypothyroidism, hypoparathyroidism

7.Connective tissue disorders including systemic sclerosis, dermatomyositis or polymyositis, systemic lupus erythematosus,amyloidosis.

8.Pregnant females

9.Refusal to give consent.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution.Timepoint: Within 24 hours

Secondary Outcome Measures

Name	Time	Method
Adverse effects related to the treatment and need for atropine usageTimepoint: 7 days;Calorie intake in 7 daysTimepoint: 7 days;Change in intra-abdominal pressure after resolution (IAP before and after)Timepoint: 24 hours;Change in SOFA score, APACHE scoreTimepoint: 7 days;New onset organ failure,New onset SBP,New onset infections,Need for rescue treatment.Timepoint: 7 days;Proportion of patients having passage of stool after intravenous neostigmine within 24-hours.Timepoint: 24 hours;Proportion of patients showing radiological resolution within 48-Hours and 72- hoursTimepoint: within 48-Hours and 72- hours;Serial change in gastric residual volumes (GRV)Timepoint: 24 hours;Stool microbiome study based on 16S RNA sequencing (Sample willbe stored in bio-bank).Timepoint: 7 days;Survival at 7-daysTimepoint: 7 days;Time to passage of stool in between two groupsTimepoint: 24 hours