To Study the Efficacy of Intravenous Neostigmine in Resolution of Acute GI Paralysis in Critically Ill Cirrhotics

NCT06462872 | Not Yet Recruiting

• 1 other identifier: ILBS-Cirrhosis-66
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To determine the efficacy of intravenous neostigmine in the resolution of acute GI paralysis in patients with Critically Ill Cirrhosis (CIC). Study population: Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance. Study period - 1 years Sample Size • All the consecutive patients admitted in liver ICU during the study time period (Dec 2023 -September 2024) will be screened and those patients meeting with inclusion and exclusion criteria will be enrolled, we intend to enroll 70 patients for the study.

Conditions

Critically Ill Cirrhotics

Outcome Measures

Primary Outcomes (1)

• To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution.

  24 hours

Secondary Outcomes (15)

• Proportion of patients having passage of stool after intravenous neostigmine within 24-hours.

  24 hours

• Time to passage of stool in between two groups.

  7 days

• Change in intra-abdominal pressure after resolution (IAP before and after)

  7 days

• Serial change in gastric residual volumes (GRV)

  7 days

• Calorie intake in 7 days

  7 days

Study Arms (1)

Critically ill cirrhotics

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

Other: observational study

Interventions

observational study OTHER

It is an observational study

Critically ill cirrhotics

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance.
• Patients with new onset lower GI tract paralysis with clinical presentation of feed intolerance defined as GRV\> 500ml, abdominal distension, bowel distension on abdominal imaging, and absence of bowel sounds.

You may not qualify if:

• Recent GI bleed
• Bronchoconstriction
• Bradycardia
• Current or past history of surgical abdomen, including mechanical obstruction, mesenteric ischemia, perforation or requiring abdominal surgery.
• 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.
• Endocrinological illnesses like uncontrolled hypothyroidism, hypoparathyroidism
• Connective tissue disorders including systemic sclerosis, dermatomyositis or polymyositis, systemic lupus erythematosus,amyloidosis.
• Pregnant females
• Refusal to give consent.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Dr Ibrara Khan, MD

CONTACT

01146300000; ibrarkhangmc29@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 17, 2024
• Study Start: June 15, 2024
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

IN (1)