Phase 2
Completed N=80
Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
Acute Pancreatitis · Intra-abdominal Hypertension
Source: ClinicalTrials.gov NCT02543658 ↗
Enrolled (actual)
80
Serious AEs
15.0%
Results posted
Aug 2020
Primary outcomePrimary: Percent Change of IAP After Treatment — -18.7; -5.4; -27.2; -20.0 percent change of IAP
Summary
Acute pancreatitis(A) often complicated with Intra-abdominal Hypertension. After the onset of acute pancreatitis, capillary leakage causing ascites,upper gastrointestinal tract obstruction and paralytic ileus leading to an elevated IAP, severe IAH leads to ACS with high mortality. Neostigmine is an anti-cholinesterase drugs, can enhance intestinal peristalsis, promote flatus defecation. The aim of this study was to determine the effect of neostigmine on reducing abdominal pressure and clinical prognosis in patients with AP by promoting intestinal peristalsis and defecation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change of IAP After Treatment |
-18.7; -5.4; -27.2; -20.0 | — |
| SECONDARY The Change of Stool Volume at 1-7 Days After Randomization |
870; 60; 1025; 370 | — |
| SECONDARY New-onset Abdominal Compartment Syndrom |
2; 4 | — |
| SECONDARY New-onset Organ Failure |
12; 16 | — |
| SECONDARY Death of 90 Days |
10; 11 | — |
| SECONDARY Timing of Enteral Nutrition |
3; 4 | — |
| SECONDARY Number of Participants With Deterioration of IAH |
4; 8 | — |
| SECONDARY Number of Participants With Adverse Effects on the Cardiovascular System |
8; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-70 year ;
- The diagnosis of acute pancreatitis according to the revised Atlanta classification.
- IAH is defined as IAP ≥ 12 mmHg by the World Society of Abdominal;Compartment Syndrome (WSACS);
- After 24 hours of conventional treatment(such as gastrointestinal decompression or percutaneous drainage of ascites), the IAP of AP patients with IAH was still ≥ 12 mmHg;
- The onset time of acute pancreatitis was within 2 weeks;
- Signed the informed consent.
Exclusion Criteria
- Previous history of laparotomy;
- Mechanical ileus or abdominal hemorrhage were considered clinically;
- Those who have contraindications to neostigmine: 1) Patients with angina; 2) myocardial infarction; 3) ventricular tachycardia; 4) bradycardia; 5) acute circulatory failure; 6) epilepsy; 7) bronchial asthma; 8) mechanical intestinal obstruction; 9) urinary tract infarction; 10) hyperthyroidism; 11) serious arrhythmia; 12) bladder operation; 13) intestinal fistula;
- Allergic to neostigmine;
- Pregnant or lactating patients.
Data sourced from ClinicalTrials.gov (NCT02543658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.