NCT04130230

Adjuvant Use of Neostigmine in Sepsis and Septic Shock.

Safety and Efficacy of Neostigmine Infusion as Adjuvant Therapy in Sepsis and Septic Shock

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis, Septic Shock

Interventions

Type	Name	Description
DRUG	Neostigmine	Neostigmine continuous infusion plus standard therapy for sepsis and septic shock.
DRUG	Standard therapy	Standard therapy for sepsis and septic shock

Timeline

• Start date: 2019-03-06
• Primary completion: 2021-08-10
• Completion: 2021-10-01
• First posted: 2019-10-17
• Last updated: 2024-07-10

Locations

1 site across 1 country: Egypt