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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically ill cirrhotics | Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational study | Other | It is an observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution. | 24 hours |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Ibrara Khan, MD | Contact | 01146300000 | ibrarkhangmc29@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| 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 |