NCT05283083

Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

Decatecholaminisation With Dexmedetomidine for Reduction of Mortality in Septic Shock: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to determine whether the infusion of DEX in septic shock can reduce in-hospital mortality, norepinephrine infusion, need and duration for mechanical ventilation, and acute kidney injury without significant adverse events.

Detailed description

During septic shock, acute stress response includes neural and humoral autonomic flaring, which tend to be beneficial in the short term. Once shock occurs, it is a failure of the compensation trial. In addition, chronic autonomic stimulation risks myocardial injury, immunosuppression, insulin resistance, and thrombo-embolic tendency. The investigators hypothesized that dacatecholaminisation with dexmedetomidine - as calibrated by heart rate control - would reduce the in-hospital mortality in septic shock, whether the patient is mechanically ventilated or not. The study aims to determine whether the infusion of DEX in septic shock can reduce in-hospital mortality, norepinephrine infusion, need and duration for mechanical ventilation, and acute kidney injury without significant adverse events.

Conditions

• Septic Shock
• Sepsis

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	A highly-selective alpha-2 agonist with sedative, analgesic, and sympatholytic effects.

Timeline

• Start date: 2022-03-25
• Primary completion: 2023-02-01
• Completion: 2023-03-01
• First posted: 2022-03-16
• Last updated: 2023-05-06

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study