Trial · NCT02543658
Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
NCT02543658, Phase 2, Completed, The First Affiliated Hospital of Nanchang University; results first posted 2020-08-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension. Trials, record NCT02543658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02543658
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
- NCT number
- NCT02543658
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Conditions
- Acute Pancreatitis, Intra-abdominal Hypertension
- Interventions
- Neostigmine Methylsulfate 1 MG/ML, Conservative treatment
- First posted
- 2015-09-07
- Last updated
- 2021-10-05
- Results first posted
- 2020-08-06
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change of IAP After Treatment | From randomization to 7 days after treatment,Measured IAP every 6 hours | Monitor the intra-abdominal pressure within 1 to 7 days after randomization, and calculate the percent change compared with that before randomization |
| Secondary | The Change of Stool Volume at 1-7 Days After Randomization | From randomization to 7 days | After 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. |
| Secondary | New-onset Abdominal Compartment Syndrom | From randomization to discharge or death, assessed up to 4 weeks | Abdominal 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 |
| Secondary | New-onset Organ Failure | From randomization to discharge or death, assessed up to 3 months | Incidence of organ failure from randomization to discharge or death, assessed up to 3 months |
| Secondary | Death of 90 Days | From randomization to 90 days after onset. | Death during from randomization to 90 days after onset. |
| Secondary | Timing of Enteral Nutrition | Start time of enteral nutrition after randomization, assessed up to 30 days | From date of randomization to enteral nutrition, assessed up to 30 days |
| Secondary | Number of Participants With Deterioration of IAH | From randomization to 7 days | IAP rebound ≥ 5mmHg or increase ≥ 20mmHg within 1-7 days after grouping |
| Secondary | Number of Participants With Adverse Effects on the Cardiovascular System | From randomization to 7 days | Due 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 |
| Other | Days in Hospital | From randomisation to 6 months | Days in hospital within 6 months after randomisation |
| Other | Days in ICU | From randomisation to 6 months | Days in ICU within 6 months after randomisation |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change of IAP After Treatment | From randomization to 7 days after treatment,Measured IAP every 6 hours | The primary outcome measure was decreased rate of IAP after randomisation. | percent change of IAP | MEDIAN |
| SECONDARY | The Change of Stool Volume at 1-7 Days After Randomization | From randomization to 7 days | ml/day | MEDIAN | |
| SECONDARY | New-onset Abdominal Compartment Syndrom | From randomization to discharge or death, assessed up to 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | New-onset Organ Failure | From randomization to discharge or death, assessed up to 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Death of 90 Days | From randomization to 90 days after onset. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Timing of Enteral Nutrition | Start time of enteral nutrition after randomization, assessed up to 30 days | days | MEDIAN | |
| SECONDARY | Number of Participants With Deterioration of IAH | From randomization to 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Effects on the Cardiovascular System | From randomization to 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Days in Hospital | From randomisation to 6 months | days | MEDIAN | |
| OTHER_PRE_SPECIFIED | Days in ICU | From randomisation to 6 months | days | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change of IAP After Treatment | Neostigmine | percent change of IAP at 24 hours | -18.7 | Inter-Quartile Range -28.4 to -4.7 | percent change of IAP |
| Percent Change of IAP After Treatment | Conservative Treatment | percent change of IAP at 24 hours | -5.4 | Inter-Quartile Range -18.0 to 0 | percent change of IAP |
| Percent Change of IAP After Treatment | Neostigmine | percent change of IAP at 7 days | -27.2 | Inter-Quartile Range -39.4 to -5.3 | percent change of IAP |
| Percent Change of IAP After Treatment | Conservative Treatment | percent change of IAP at 7 days | -20.0 | Inter-Quartile Range -26.7 to -5.9 | percent change of IAP |
| The Change of Stool Volume at 1-7 Days After Randomization | Neostigmine | The change of stool volume at 24 hours | 870 | Inter-Quartile Range 250 to 2070 | ml/day |
| The Change of Stool Volume at 1-7 Days After Randomization | Conservative Treatment | The change of stool volume at 24 hours | 60 | Inter-Quartile Range -30 to 770 | ml/day |
| The Change of Stool Volume at 1-7 Days After Randomization | Neostigmine | The change of stool volume at 7th day | 1025 | Inter-Quartile Range 450 to 1520 | ml/day |
| The Change of Stool Volume at 1-7 Days After Randomization | Conservative Treatment | The change of stool volume at 7th day | 370 | Inter-Quartile Range 150 to 1200 | ml/day |
| New-onset Abdominal Compartment Syndrom | Neostigmine | 2 | Participants | ||
| New-onset Abdominal Compartment Syndrom | Conservative Treatment | 4 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Neostigmine | 40 | |
| Overall Study | STARTED | The Traditional Treatment | 40 | |
| Overall Study | COMPLETED | Neostigmine | 40 | |
| Overall Study | COMPLETED | The Traditional Treatment | 36 | |
| Overall Study | NOT COMPLETED | Neostigmine | 0 | |
| Overall Study | NOT COMPLETED | The Traditional Treatment | 4 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Single cardiovascular failure | Cardiac disorders | Neostigmine | 3 | 40 | 3 |
| serious | Single cardiovascular failure | Cardiac disorders | The Traditional Treatment | 3 | 40 | 3 |
| serious | Cardiovascular and respiratory failure | Cardiac disorders | Neostigmine | 2 | 40 | 2 |
| serious | Cardiovascular and respiratory failure | Cardiac disorders | The Traditional Treatment | 0 | 40 | 0 |
| serious | Cardiovascular and renal failure | Cardiac disorders | Neostigmine | 1 | 40 | 1 |
| serious | Cardiovascular and renal failure | Cardiac disorders | The Traditional Treatment | 1 | 40 | 1 |
| serious | Cardiovascular, respiratory and renal failure | Cardiac disorders | Neostigmine | 2 | 40 | 2 |
| serious | Cardiovascular, respiratory and renal failure | Cardiac disorders | The Traditional Treatment | 0 | 40 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neostigmine | 10 | 40 |
| Total, all-cause mortality | The Traditional Treatment | 11 | 40 |
| Total, other adverse events | Neostigmine | 0 | 40 |
| Total, other adverse events | The Traditional Treatment | 0 | 40 |
| Total, serious adverse events | Neostigmine | 8 | 40 |
| Total, serious adverse events | The Traditional Treatment | 4 | 40 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Neostigmine vs Conservative Treatment: Number of Participants With Adverse Effects on the Cardiovascular System | Trial comparisons |
| Neostigmine vs Conservative Treatment: New-onset Organ Failure | Trial comparisons |
| Neostigmine vs Conservative Treatment: New-onset Abdominal Compartment Syndrom | Trial comparisons |
| Neostigmine vs Conservative Treatment: Death of 90 Days | Trial comparisons |
| Neostigmine vs Conservative Treatment: Number of Participants With Deterioration of IAH | Trial comparisons |
| Neostigmine vs The Traditional Treatment: deaths from any cause | Trial comparisons |
| Neostigmine vs The Traditional Treatment: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02543658
GET https://conductscience.org/api/trials/v1/NCT02543658/results?page=2