Critically Ill CirrhoticsNCT06462872
To Study the Efficacy of Intravenous Neostigmine in Resolution of Acute GI Paralysis in Critically Ill Cirrhotics
An observational study of Critically Ill Cirrhotics, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Critically Ill Cirrhotics
- What is being tested?
- observational study
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jun 2024to 27 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance.
Who may be able to join
- 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.
Who cannot join
- 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
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- Connective tissue disorders including systemic sclerosis, dermatomyositis or polymyositis, systemic lupus erythematosus,amyloidosis.
- Pregnant females
- Refusal to give consent.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Ibrara Khan, MD, 011, ibrarkhangmc29@gmail.com
About this study
Official title: To Study the Efficacy of Intravenous Neostigmine in Resolution of Acute GI Paralysis in Critically Ill Cirrhotics-Prospective Observational Study
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.
Read the 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.
- Conditions
- Critically Ill Cirrhotics
- Being tested
- observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
It is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Critically ill cirrhotics | Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance. Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution.
Measured: 24 hours
Secondary outcomes (15)
Proportion of patients having passage of stool after intravenous neostigmine within 24-hours.
Measured: 24 hours
Time to passage of stool in between two groups.
Measured: 7 days
Change in intra-abdominal pressure after resolution (IAP before and after)
Measured: 7 days
Serial change in gastric residual volumes (GRV)
Measured: 7 days
Calorie intake in 7 days
Measured: 7 days
Change in SOFA score.
Measured: 7 days
Change in APACHE score
Measured: 7 days
Number of patients with new onset organ failure
Measured: 7 days
Number of patients with new onset SBP
Measured: 7 days
Number of patients with new onset infections
Measured: 7 days
Number of patients with need for rescue treatment.
Measured: 7 days
Proportion of patients showing radiological resolution within 48-Hours and 72- hours.
Measured: within 48-Hours and 72- hours
Adverse effects related to the treatment and need for atropine usage.
Measured: 7 days
Survival at 7-days
Measured: 7 days
Stool microbiome study based on 16S RNA sequencing (Sample willbe stored in bio-bank).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion27 Feb 2025 (estimated)
- Study completion27 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill CirrhoticsStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462872
- Sponsor's protocol ID
- ILBS-Cirrhosis-66
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Efficacy of Intravenous Neostigmine in Resolution of Acute GI Paralysis in Critically Ill Cirrhotics-Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06462872
- Acronym / sponsor ID
- ILBS-Cirrhosis-66
- Conditions
- Critically Ill Cirrhotics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 27 Feb 2025 (estimated)
- Study completion
- 27 Feb 2025 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill cirrhotics | – | Other: observational studyCritically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyIt is an observational study | Other | Critically ill cirrhotics |
Primary outcome
To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution.
Time frame: 24 hours
15 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Critically Ill Cirrhotics
RecruitingObservational study
Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation
Critical Illness, Cirrhosis, Liver
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill Cirrhotics, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Ibrara Khan, MD (01146300000, ibrarkhangmc29@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.