Clinical trial NCT05283083: Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality
Official title: Decatecholaminisation With Dexmedetomidine for Reduction of Mortality in Septic Shock: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Septic Shock
Sepsis
Keywords: dexmedetomidine
randomized controlled trial
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open label randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult (≥ 18 years) patients of either sex who develop septic shock with heart rate (HR) \> 90 beats per minute (bpm).

We choose the definition of septic shock as the start of norepinephrine (NE) infusion to maintain the mean arterial blood pressure (MAP) of ≥ 65 mmHg in a case of sepsis (≥ 2 SIRS criteria plus suspicion or confirmation of infection).

Exclusion Criteria:

* Patient refusal or inability to obtain consent
* Failure of hemodynamic stabilization or hemoglobin \< 7 gm/dl at time of inclusion
* Severe cardiac dysfunction (Ejection Fraction (EF) \< 30%)
* History of heart block or patient on pacemaker
* Chronic liver Disease (Child-Pugh classification C)
* Severe valvular heart disease
* Pregnancy

Primary outcomes:
measure: In-hospital mortality
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Norepinephrine equivalent dose (NED)
timeFrame: over the first 3 days after enrolment or death, which comes first
measure: Need for epinephrine infusion
timeFrame: over the first 3 days after enrolment or death, which comes first
measure: Heart rate (HR) beat per minute
timeFrame: over the first 3 days after enrolment or death, which comes first
measure: Mean arterial blood pressure (MAP) mmHg
timeFrame: over the first 3 days after enrolment or death, which comes first
measure: Initiation of invasive mechanical ventilation (IMV) in non-ventilated patients
timeFrame: Through study completion, an average of 3 months
measure: Early acute kidney injury
timeFrame: 48 hours after ICU admission in previously normal kidney function
measure: Late acute kidney injury
timeFrame: 7 days after ICU admission in previously normal kidney function
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
state: Aldakahlia
Study officials:
affiliation: Mansoura University Faculty of Medicine
name: Moataz M Emara, MD, EDAIC
role: STUDY_DIRECTOR
References: