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Randomized controlled trial: neostigmine for intra-abdominal hypertension in acute pancreatitis.
- Source :
-
Critical care (London, England) [Crit Care] 2022 Mar 03; Vol. 26 (1), pp. 52. Date of Electronic Publication: 2022 Mar 03. - Publication Year :
- 2022
-
Abstract
- Background: Intra-abdominal hypertension (IAH) in acute pancreatitis (AP) is associated with deterioration in organ function. This trial aimed to assess the efficacy of neostigmine for IAH in patients with AP.<br />Methods: In this single-center, randomized trial, consenting patients with IAH within 2 weeks of AP onset received conventional treatment for 24 h. Patients with sustained intra-abdominal pressure (IAP) ≥ 12 mmHg were randomized to receive intramuscular neostigmine (1 mg every 12 h increased to every 8 h or every 6 h, depending on response) or continue conventional treatment for 7 days. The primary outcome was the percent change of IAP at 24 h after randomization.<br />Results: A total of 80 patients were recruited to neostigmine (n = 40) or conventional treatment (n = 40). There was no significant difference in baseline parameters. The rate of decrease in IAP was significantly faster in the neostigmine group compared to the conventional group by 24 h (median with 25th-75th percentile: -18.7% [- 28.4 to - 4.7%] vs. - 5.4% [- 18.0% to 0], P = 0.017). This effect was more pronounced in patients with baseline IAP ≥ 15 mmHg (P = 0.018). Per-protocol analysis confirmed these results (P = 0.03). Stool volume was consistently higher in the neostigmine group during the 7-day observational period (all P < 0.05). Other secondary outcomes were not significantly different between neostigmine and conventional treatment groups.<br />Conclusion: Neostigmine reduced IAP and promoted defecation in patients with AP and IAH. These results warrant a larger, placebo-controlled, double-blind phase III trial. Trial registration Clinical Trial No: NCT02543658 (registered August /27, 2015).<br /> (© 2022. The Author(s).)
Details
- Language :
- English
- ISSN :
- 1466-609X
- Volume :
- 26
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Critical care (London, England)
- Publication Type :
- Academic Journal
- Accession number :
- 35241135
- Full Text :
- https://doi.org/10.1186/s13054-022-03922-4