To Study the Efficacy of Intravenous Neostigmine in Resolution of Acute GI Paralysis in Critically Ill Cirrhotics-Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution.
Study Overview
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.
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
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Patient to receive slow intravenous infusion of Neostigmine, 1 mg over 5-10 minutes repeated 8 hourly for first 24 hours.
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Administration of Neostigmine will include defined steps for prevention of adverse event:
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Neostigmine, 1 mg, intravenous infusion over 3-5 min
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Atropine available at bedside Patient kept supine
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Continuous electrocardiographic monitoring with vital signs for30 min
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Continuous clinical assessment for 15-30 min
Patients who do not give consent for the intervention will receive the standard of care treatment.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution.
Time Frame: 24 hours
Secondary Outcomes
- Proportion of patients showing radiological resolution within 48-Hours and 72- hours.(within 48-Hours and 72- hours)
- 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)
- 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 need for rescue treatment.(7 days)
- Serial change in gastric residual volumes (GRV)(7 days)
- Calorie intake in 7 days(7 days)
- Number of patients with new onset SBP(7 days)
- Survival at 7-days(7 days)
- Stool microbiome study based on 16S RNA sequencing (Sample willbe stored in bio-bank).(7 days)
- Adverse effects related to the treatment and need for atropine usage.(7 days)
- Number of patients with new onset infections(7 days)