Trial Outcomes & Findings for Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension (NCT NCT02543658)
NCT ID: NCT02543658
Last Updated: 2021-10-05
Results Overview
Monitor the intra-abdominal pressure within 1 to 7 days after randomization, and calculate the percent change compared with that before randomization
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
From randomization to 7 days after treatment,Measured IAP every 6 hours
Results posted on
2021-10-05
Participant Flow
Between Sept 1, 2015, and Aug 15, 2017, we measured intra-abdominal pressure on patients with acute pancreatitis and selected patients with intra-abdominal hypertension, in the Pancreatic Intensive Care Unit of the Department of Gastroenterology, the First Affiliated Hospital of Nanchang University.
Acute pancreatitis patients with intra-abdominal hypertension were first treated with conventional non-surgical therapy(such as: Enteral decompression with nasogastric and rectal tube,Glycerin enema, percutaneous drainage of ascites) for 24 hours. After 24 hours, the intra-abdominal pressure was still above 12 mmHg and they were randomized.
Participant milestones
| Measure |
Neostigmine
Intramuscular injection of neostigmine
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.
|
The Traditional Treatment
Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Neostigmine
Intramuscular injection of neostigmine
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.
|
The Traditional Treatment
Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
4
|
Baseline Characteristics
Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
Baseline characteristics by cohort
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 yeas
STANDARD_DEVIATION 13 • n=5 Participants
|
49 yeas
STANDARD_DEVIATION 14 • n=7 Participants
|
48 yeas
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Cause of pancreatitis
Biliary
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Cause of pancreatitis
Hyperlipidemic
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Cause of pancreatitis
Alcoholic
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Cause of pancreatitis
Idiopathic
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to 7 days after treatment,Measured IAP every 6 hoursPopulation: The primary outcome measure was decreased rate of IAP after randomisation.
Monitor the intra-abdominal pressure within 1 to 7 days after randomization, and calculate the percent change compared with that before randomization
Outcome measures
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
|---|---|---|
|
Percent Change of IAP After Treatment
percent change of IAP at 24 hours
|
-18.7 percent change of IAP
Interval -28.4 to -4.7
|
-5.4 percent change of IAP
Interval -18.0 to 0.0
|
|
Percent Change of IAP After Treatment
percent change of IAP at 7 days
|
-27.2 percent change of IAP
Interval -39.4 to -5.3
|
-20.0 percent change of IAP
Interval -26.7 to -5.9
|
SECONDARY outcome
Timeframe: From randomization to 7 daysAfter randomization, the change of stool volume (ML) was calculated every 24 hours.For example, the amount of stool volume decreased or increased in 24 hours after grouping compared to before grouping.
Outcome measures
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
|---|---|---|
|
The Change of Stool Volume at 1-7 Days After Randomization
The change of stool volume at 24 hours
|
870 ml/day
Interval 250.0 to 2070.0
|
60 ml/day
Interval -30.0 to 770.0
|
|
The Change of Stool Volume at 1-7 Days After Randomization
The change of stool volume at 7th day
|
1025 ml/day
Interval 450.0 to 1520.0
|
370 ml/day
Interval 150.0 to 1200.0
|
SECONDARY outcome
Timeframe: From randomization to discharge or death, assessed up to 4 weeksAbdominal compartment syndrome is defined as a sustained IAP\>20 mmHg (with or without an APP\<60 mmHg) that is associated with new organ dysfunction/failure
Outcome measures
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
|---|---|---|
|
New-onset Abdominal Compartment Syndrom
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From randomization to discharge or death, assessed up to 3 monthsIncidence of organ failure from randomization to discharge or death, assessed up to 3 months
Outcome measures
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
|---|---|---|
|
New-onset Organ Failure
|
12 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From randomization to 90 days after onset.Death during from randomization to 90 days after onset.
Outcome measures
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
|---|---|---|
|
Death of 90 Days
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Start time of enteral nutrition after randomization, assessed up to 30 daysFrom date of randomization to enteral nutrition, assessed up to 30 days
Outcome measures
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
|---|---|---|
|
Timing of Enteral Nutrition
|
3 days
Interval 3.0 to 4.0
|
4 days
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: From randomization to 7 daysIAP rebound ≥ 5mmHg or increase ≥ 20mmHg within 1-7 days after grouping
Outcome measures
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
|---|---|---|
|
Number of Participants With Deterioration of IAH
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From randomization to 7 daysDue to that neostigmine has an inhibitory effect on the cardiovascular system, new-onset cardiovascular failure after grouping is considered as a possible adverse event related to neostigmine.Cardiovascular failure was defined as circulatory systolic blood pressure \<90 mm Hg, despite adequate fluid resuscitation, or need for inotropic catecholamine support
Outcome measures
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
|---|---|---|
|
Number of Participants With Adverse Effects on the Cardiovascular System
|
8 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomisation to 6 monthsDays in hospital within 6 months after randomisation
Outcome measures
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
|---|---|---|
|
Days in Hospital
|
20 days
Interval 13.0 to 31.0
|
19 days
Interval 14.0 to 27.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomisation to 6 monthsDays in ICU within 6 months after randomisation
Outcome measures
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
|---|---|---|
|
Days in ICU
|
12 days
Interval 7.0 to 19.0
|
12 days
Interval 8.0 to 15.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomisation to 6 monthsMedical expenses within 6 months after randomisation
Outcome measures
| Measure |
Neostigmine
n=40 Participants
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
Conservative Treatment
n=40 Participants
Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
|
|---|---|---|
|
Medical Expenses
|
95.3 thousand(RMB)
Interval 58.7 to 146.8
|
102.3 thousand(RMB)
Interval 56.0 to 186.6
|
Adverse Events
Neostigmine
Serious events: 8 serious events
Other events: 0 other events
Deaths: 10 deaths
The Traditional Treatment
Serious events: 4 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Neostigmine
n=40 participants at risk
Intramuscular injection of neostigmine
Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.
Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.
|
The Traditional Treatment
n=40 participants at risk
Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.
|
|---|---|---|
|
Cardiac disorders
Single cardiovascular failure
|
7.5%
3/40 • Number of events 3 • 6 months
The main adverse events observed were the effects of neostigmine on the cardiovascular system, such as arrhythmias and decreased blood pressure
|
7.5%
3/40 • Number of events 3 • 6 months
The main adverse events observed were the effects of neostigmine on the cardiovascular system, such as arrhythmias and decreased blood pressure
|
|
Cardiac disorders
Cardiovascular and respiratory failure
|
5.0%
2/40 • Number of events 2 • 6 months
The main adverse events observed were the effects of neostigmine on the cardiovascular system, such as arrhythmias and decreased blood pressure
|
0.00%
0/40 • 6 months
The main adverse events observed were the effects of neostigmine on the cardiovascular system, such as arrhythmias and decreased blood pressure
|
|
Cardiac disorders
Cardiovascular and renal failure
|
2.5%
1/40 • Number of events 1 • 6 months
The main adverse events observed were the effects of neostigmine on the cardiovascular system, such as arrhythmias and decreased blood pressure
|
2.5%
1/40 • Number of events 1 • 6 months
The main adverse events observed were the effects of neostigmine on the cardiovascular system, such as arrhythmias and decreased blood pressure
|
|
Cardiac disorders
Cardiovascular, respiratory and renal failure
|
5.0%
2/40 • Number of events 2 • 6 months
The main adverse events observed were the effects of neostigmine on the cardiovascular system, such as arrhythmias and decreased blood pressure
|
0.00%
0/40 • 6 months
The main adverse events observed were the effects of neostigmine on the cardiovascular system, such as arrhythmias and decreased blood pressure
|
Other adverse events
Adverse event data not reported
Additional Information
Wenhua He
First affilitated hospital of Nanchang university
Phone: +8613879182642
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place