Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

Mansoura University90 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Septic Shock Sepsis

Interventions

DexmedetomidineDRUG

A highly-selective alpha-2 agonist with sedative, analgesic, and sympatholytic effects.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mansoura University Hospitals

Al Mansurah, Aldakahlia, Egypt

Outcomes

Primary Outcomes

In-hospital mortality

The investigators will review the patient status on discharge from the hospital, alive or dead

Time frame: Through study completion, an average of 3 months

Secondary Outcomes

Norepinephrine equivalent dose (NED)

reported as the average of the serial measurements; the NED of epinephrine will be estimated as 1:1 ratio, reported as mcg/kg/min (Shruti Goradia et al, 2021)

Time frame: over the first 3 days after enrolment or death, which comes first

Need for epinephrine infusion

Categorical variable (as yes/no outcome)

Time frame: over the first 3 days after enrolment or death, which comes first

Heart rate (HR) beat per minute

reported as the average of the serial measurements

Time frame: over the first 3 days after enrolment or death, which comes first

Mean arterial blood pressure (MAP) mmHg

reported as the average of the serial measurements

Time frame: over the first 3 days after enrolment or death, which comes first

Initiation of invasive mechanical ventilation (IMV) in non-ventilated patients

Categorical variable (as yes/no outcome)

Time frame: Through study completion, an average of 3 months

Early acute kidney injury

Categorical variable (as yes/no outcome) - as defined by Khwaja, A., 2012. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clinical Practice, 120(4), pp.c179-c184.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.