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 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
48
It is an observational study
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution.
Time frame: 24 hours
Proportion of patients having passage of stool after intravenous neostigmine within 24-hours.
Time frame: 24 hours
Time to passage of stool in between two groups.
Time frame: 7 days
Change in intra-abdominal pressure after resolution (IAP before and after)
Time frame: 7 days
Serial change in gastric residual volumes (GRV)
Time frame: 7 days
Calorie intake in 7 days
Time frame: 7 days
Change in SOFA score.
Time frame: 7 days
Change in APACHE score
Time frame: 7 days
Number of patients with new onset organ failure
Time frame: 7 days
Number of patients with new onset SBP
Time frame: 7 days
Number of patients with new onset infections
Time frame: 7 days
Number of patients with need for rescue treatment.
Time frame: 7 days
Proportion of patients showing radiological resolution within 48-Hours and 72- hours.
Time frame: within 48-Hours and 72- hours
Adverse effects related to the treatment and need for atropine usage.
Time frame: 7 days
Survival at 7-days
Time frame: 7 days
Stool microbiome study based on 16S RNA sequencing (Sample willbe stored in bio-bank).
Time frame: 7 days
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