drugset / Trial / NCT04130230

Adjuvant Use of Neostigmine in Sepsis and Septic Shock.

NCT04130230 ↗

Phase 2 Completed 50 enrolled Mansoura University
RandomizedParallel-groupSingle-blindTreatment

Summary

The inflammatory response represents an important, central component of sepsis. Therefore, it is believed that blunting inflammation will decrease mortality. In vivo test series with mice that had undergone cecal ligation and puncture (recognized sepsis model), physostigmine salicylate significantly inhibited the release of various cytokines (tumor necrosis factor α, interleukin1β, and interleukin 6). These results were similar to those obtained by vagus nerve stimulation. In animal sepsis model using physostigmine not only decreased inflammation but also, diminished the decrease in blood pressure following infection. Animals treated with the peripheral choline esterase inhibitor neostigmine showed no difference compared with physostigmine-treated animals. Therefore, this study aims to investigate the efficacy of choline esterase inhibitors as adjuvant therapy in patients with sepsis or septic shock. Outcome measures include: percentage reduction in procalcitonin blood level, percentage of patients achieving significant reduction in procalcitonin levels, Mean Sequential Organ Failure Assessment score, percentage decrease in lactate dehydrogenase blood level, length of stay in hospital intensive care unit, and in hospital mortality.

Timeline

Start
2019-03-06
Primary completion
2021-08-10
Completion
2021-10-01

Outcome

Met primary endpoint

paper SOFA scores improved significantly in the neostigmine arm [-2 (-5, 1)] as compared with the control arm [1.5 (0, 2.8); p = 0.007]. PMID 35330830 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Neostigmine Other / unclassified 0.2 mg Other