Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

Sepsis Clinical Trial

— DECATSepsis  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283083
• Other study ID #: MS.22.02.1889
• Status: Completed
• Phase: Phase 2
• Start date: March 25, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: May 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Dexmedetomidine
A highly-selective alpha-2 agonist with sedative, analgesic, and sympatholytic effects.

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansoura	Aldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality	The investigators will review the patient status on discharge from the hospital, alive or dead	Through study completion, an average of 3 months
Secondary	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)	over the first 3 days after enrolment or death, which comes first
Secondary	Need for epinephrine infusion	Categorical variable (as yes/no outcome)	over the first 3 days after enrolment or death, which comes first
Secondary	Heart rate (HR) beat per minute	reported as the average of the serial measurements	over the first 3 days after enrolment or death, which comes first
Secondary	Mean arterial blood pressure (MAP) mmHg	reported as the average of the serial measurements	over the first 3 days after enrolment or death, which comes first
Secondary	Initiation of invasive mechanical ventilation (IMV) in non-ventilated patients	Categorical variable (as yes/no outcome)	Through study completion, an average of 3 months
Secondary	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.	48 hours after ICU admission in previously normal kidney function
Secondary	Late acute kidney injury	Categorical variable (as yes/no outcome) - as defined by the Khwaja, A., 2012. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clinical Practice, 120(4), pp.c179-c184.	7 days after ICU admission in previously normal kidney function