A Phase 2 interventional study of Dexmedetomidine in Septic Shock and Sepsis, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Mansoura University · Phase 2, Interventional, and Treatment
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.
861 studies on the registry are indexed under Shock, Septic; 206 are open to participants now.
This study's enrollment of 90 is above the median of 79 across 529 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Patients will receive dexmedetomidine infusion according to the protocol plus the usual care. We will evaluate patients for inclusion in the study after 6 hours on NE infusion, given stabilization of the MAP \> 65 mmHg. In the DEX group, we will commence DEX infusion at the rate of 0.2 mcg.kg-1.h-1 without a loading dose, then titrate DEX infusion to maintain the HR from 60 to 90 bpm. Titration of the DEX infusion rate will not be more than 0.1 mcg.kg-1.h-1 every 30 minutes at any time. The maximum DEX infusion rate will be 0.7 mcg.kg-1.h-1. We aim to continue DEX infusion for 48 hours. After 48 hours of DEX infusion, we will taper the DEX infusion over one hour. According to our protocol, DEX infusion would trigger either STOP events or hemodynamic assessment events:
Drug: Dexmedetomidine
The patients in this group will receive the usual care.
A highly-selective alpha-2 agonist with sedative, analgesic, and sympatholytic effects.
Also known as: Precedex, Dexdor, Dexdomitor, Sileo
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
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.
Time frame: 48 hours after ICU admission in previously normal kidney function
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.
Time frame: 7 days after ICU admission in previously normal kidney function
Plan to share: Yes — The anonymously patient data will be available on reasonable request - according to the local IRB approval - from the corresponding author and the central study contact, Moataz Emara at mm.emara@mans.edu.eg or mm.emara@yahoo.com.
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Mansoura University