Role of Neostigmine in patients severe infection with low blood pressure

Effect of Neostigmine on outcomes in patients with Septic Shock: A Double-blind Randomized Controlled Trial - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079070

Enrollment

Registered

2025-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R652- Severe sepsis

Interventions

Intervention1: Neostigmine infusion: 2.0 ml/hr for 5 days Control Intervention1: Saline infusion: 2.0 ml/hr for 5 days

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients who are admitted to the ICU with septic shock of less than 24-hour duration

Exclusion criteria

Exclusion criteria: Patients who refuse to consent for the study. Patients with SOFA score of 6 or more. Patients with asthma, bradycardia or heart block, head injury, muscle dystrophy, urinary or gastrointestinal obstruction. Pregnant patients or lactating mothers Patients with known allergy to neostigmine.

Design outcomes

Primary

Measure	Time frame
SOFA scoreTimepoint: Day five post ICU admission	—

Secondary

Measure	Time frame
Relative change in SOFA score (deltaSOFA) from baselineTimepoint: Day five post ICU admission;Ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2)Timepoint: Day 0(baseline), 3, 5 and 7 post ICU admission;GCS scoreTimepoint: Day 0(baseline), 3, 5 and 7 post ICU admission;Reversal of shockTimepoint: Day 3, 5 and 7 post ICU admission;Need for mechanical ventilationTimepoint: Day 0(baseline), 3, 5 and 7 post ICU admission;Successful extubationTimepoint: Day 3, 5 and 7 post ICU admission;MortalityTimepoint: 28 days post ICU admission;Length of ICU stayTimepoint: 28 days post ICU admission;Length of hospital stayTimepoint: 28 days post ICU admission;ComplicationsTimepoint: Day five post ICU admission	—

Measure

Time frame

Relative change in SOFA score (deltaSOFA) from baselineTimepoint: Day five post ICU admission;Ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2)Timepoint: Day 0(baseline), 3, 5 and 7 post ICU admission;GCS scoreTimepoint: Day 0(baseline), 3, 5 and 7 post ICU admission;Reversal of shockTimepoint: Day 3, 5 and 7 post ICU admission;Need for mechanical ventilationTimepoint: Day 0(baseline), 3, 5 and 7 post ICU admission;Successful extubationTimepoint: Day 3, 5 and 7 post ICU admission;MortalityTimepoint: 28 days post ICU admission;Length of ICU stayTimepoint: 28 days post ICU admission;Length of hospital stayTimepoint: 28 days post ICU admission;ComplicationsTimepoint: Day five post ICU admission

—

Countries

India

Contacts

Public ContactDr Deepak Singla

AIIMS Rishikesh

icubhu@gmail.com8808631209

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026