Status:
COMPLETED
Adjuvant Use of Neostigmine in Sepsis and Septic Shock.
Lead Sponsor:
Mansoura University
Conditions:
Sepsis, Septic Shock
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 und...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04130230
Start Date
March 6 2019
End Date
October 1 2021
Last Update
July 10 2024
Active Locations (1)
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1
Tanta University Hospital
Tanta, EL-Gharbia, Egypt, 31527