To Study the Efficacy of Intravenous Neostigmine in Resolution of Acute GI Paralysis in Critically Ill Cirrhotics
- Conditions
- Critically Ill Cirrhotics
- Interventions
- Other: observational study
- Registration Number
- NCT06462872
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Critically ill cirrhotics observational study Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance.
- Primary Outcome Measures
Name Time Method To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution. 24 hours
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Institute of Liver & Biliary Sciences
🇮🇳New Delhi, Delhi, India