Adjuvant Use of Neostigmine in Sepsis and Septic Shock.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-06

Study Completion Date

2021-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock

NCT05402553

Sepsis Septic Shock

UNKNOWN PHASE1/PHASE2

Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

NCT04910464

Sepsis

RECRUITING PHASE3

Midodrine Effect on the Mortality Rates in Septic Shock Patients

NCT05778838

Septic Shock

COMPLETED PHASE2

Anticholium® Per Se

NCT03013322

Shock, Septic Sepsis Perioperative Period

COMPLETED NA

Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

NCT05283083

Septic Shock Sepsis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis, Septic Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neostigmine group

This arm will receive -in addition to standard therapy for sepsis and septic shock-Neostigmine methylsulfate ampoule diluted in normal saline, and administered as continuous infusion for five days. The rate of infusion is 0.2 mg/hr.

Group Type EXPERIMENTAL

Neostigmine

Intervention Type DRUG

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

Standard group

This arm will receive the standard therapy for sepsis and septic shock only and followed for five days.

Group Type PLACEBO_COMPARATOR

Standard therapy

Intervention Type DRUG

Standard therapy for sepsis and septic shock

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neostigmine

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

Intervention Type DRUG

Standard therapy

Standard therapy for sepsis and septic shock

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Choline esterase inhibitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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:

1. Fever ≥ 38 °C or hypothermia ≤ 36 °C.
2. Tachycardia ≥ 100/min.
3. Tachypnea ≥ 20/min or hyperventilation.
4. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No