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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | 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: |
|
| Usual care without dexmedetomidine infusion | No Intervention | The patients in this group will receive the usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | A highly-selective alpha-2 agonist with sedative, analgesic, and sympatholytic effects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Need for epinephrine infusion |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Moataz M Emara, MD, EDAIC | Mansoura University Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospitals | Al Mansurah | Aldakahlia | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39004217 | Derived | Ezz Al-Regal AR, Ramzy EA, Atia AAA, Emara MM. Dexmedetomidine for Reducing Mortality in Patients With Septic Shock: A Randomized Controlled Trial (DecatSepsis). Chest. 2024 Dec;166(6):1394-1405. doi: 10.1016/j.chest.2024.06.3794. Epub 2024 Jul 14. |
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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.
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will be shared shortly.
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.
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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An open label randomized controlled trial
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There is no masking
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Categorical variable (as yes/no outcome) |
| 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 | 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 | 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) | 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. | 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. | 7 days after ICU admission in previously normal kidney function |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |