Critically Ill Cirrhotics
Conditions
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 * 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.
Interventions
OTHERobservational study
It is an observational study
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution. | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of patients having passage of stool after intravenous neostigmine within 24-hours. | 24 hours |
| 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 |
| Number of patients with new onset SBP | 7 days |
Countries
India
Contacts
Primary ContactDr Ibrara Khan, MD
Outcome results
None listed