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OpenTrials
Completed

NCT Number: NCT04130230

Adjuvant Use of Neostigmine in Sepsis and Septic Shock.

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.

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Key information

Conditions

Sepsis, Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tanta University Hospital

Tanta, EL-Gharbia, 31527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-85 years.
  • Patients diagnosed with sepsis or septic shock according to Third International Consensus Definitions for Sepsis and Septic Shock mentioned above.
  • Patients who have ≥ 2 of the following four criteria plus documented infection:
  • Fever ≥ 38 °C or hypothermia ≤ 36 °C.
  • Tachycardia ≥ 100/min.
  • Tachypnea ≥ 20/min or hyperventilation.
  • Leukocytosis ≥ 12000/mm3 or leukopenia ≤ 4000/mm3 or ≥ 10% immature neutrophils in the differential count.

Exclusion criteria

  • Known hypersensitivity to choline esterase inhibitors.
  • Known absolute contra-indications against choline esterase inhibitors such as, myotonic dystrophy; depolarization block by depolarizing muscle relaxants; intoxication by irreversibly acting cholinesterase inhibitors; closed craniocerebral trauma; obstruction in the gastrointestinal tract (mechanical constipation); obstruction in the urinary tract (mechanical urinary retention)
  • Known relative contraindications against choline esterase inhibitors: bronchial asthma; bradycardia; AV-conduction disturbances.
  • Having undergone solid organ transplantation.
  • Pregnant and lactating women.
  • Participation in another clinical trial.
  • Presence of primary or concomitant illness, impending death.

Treatment and study plan

Neostigmine

Drug

Neostigmine continuous infusion plus standard therapy for sepsis and septic shock.

Other names: Choline esterase inhibitor

Standard therapy

Drug

Standard therapy for sepsis and septic shock

Primary outcomes

  1. Sequential organ failure assessment (SOFA score)

    Time frame: Change from baseline SOFA score at five days

    Increase in SOFA score is associated with worse outcome.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 17, 2019
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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