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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critically Ill Cirrhotics
• Intervention / Treatment: Other: observational study

Detailed Description

Study Design: Prospective observational study

Intervention: Standard medical treatment (SMT)- keeping patients Nil Per Oral, I.V fluids, I.V antibiotics (antibiotic as per ICU protocol of ILBS), Ryle's tube decompression, correction of dyselectrolytemia, prokinetics

• Patient to receive slow intravenous infusion of Neostigmine, 1 mg over 5-10 minutes repeated 8 hourly for first 24 hours.

• Administration of Neostigmine will include defined steps for prevention of adverse event:

  • Neostigmine, 1 mg, intravenous infusion over 3-5 min
  • Atropine available at bedside Patient kept supine
  • Continuous electrocardiographic monitoring with vital signs for30 min
  • Continuous clinical assessment for 15-30 min

Patients who do not give consent for the intervention will receive the standard of care treatment.

Rescue treatment- Colonoscopic decompression, Flatus tube insertion, surgical intervention

Monitoring and assessment:

. An immediate clinical response was defined as the passage of flatus or stool with reduction in abdominal distention on physical examination after the injection. With clinical and radiological confirmation of resolution and re-initiation of enteral feeding, would define clinical response.

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: Dr Ibrara Khan, MD; Phone Number: 01146300000; Email: ibrarkhangmc29@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences
      • Contact: Dr Ibrara Khan, MD; Phone Number: 011; Email: ibrarkhangmc29@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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> 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; It is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution.	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in SOFA score.	7 days
Change in APACHE score	7 days
Number of patients with new onset organ failure	7 days
Number of patients with new onset SBP	7 days
Number of patients with new onset infections	7 days
Number of patients with need for rescue treatment.	7 days
Proportion of patients showing radiological resolution within 48-Hours and 72- hours.	within 48-Hours and 72- hours
Adverse effects related to the treatment and need for atropine usage.	7 days
Survival at 7-days	7 days
Stool microbiome study based on 16S RNA sequencing (Sample willbe stored in bio-bank).	7 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): February 27, 2025
• Study Completion (Estimated): February 27, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Critical Illness; Paralysis
• Other Study ID Numbers: ILBS-Cirrhosis-66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No