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Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. The investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients.
The investigators of the current study will use DEXPRESSIN in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality.
The investigator will include 260 patients with septic shock. The study will compare the use of vasopressin as the first-line vasopressor in septic shock in addition to the dexmedetomidine infusion as in the DecatSepsis trial versus the standard of care. The standard of care is guided by the Surviving Sepsis campaign in 2021.
The main outcomes of the study are in-hospital mortality, norepinephrine equivalent dose, ICU scores, and inflammatory markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEX-PRESSIN | Experimental | This group will receive vasopressin as the first-line vasopressor. DEX will be started after hemodynamic stabilization if the heart rate is >90 beats per minute (bpm). NE infusion will be the second-line vasoactive drug. |
|
| Standard-of-care group | Active Comparator | This group will receive conventional treatment according to the Surviving Sepsis Campaign 2021 guidelines. This group will receive vasopressin as the second line after NE and will not receive dexmedetomidine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEX-PRESSIN | Drug | This group will receive vasopressin as the first-line vasopressor. DEX will be started after hemodynamic stabilization if the heart rate is >90 beats per minute (bpm). NE infusion will be the second-line vasoactive drug. |
| Measure | Description | Time Frame |
|---|---|---|
| in-hospital mortality | All-cause inhospital mortality as a binary outcome | throughout the hospitalization period on average 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| survival analysis | time to die using Kaplan Mier Curve | through out the hospitalization period or 28 days after inclusion if discharged from hosptia; before 28 days |
| Norepinephrine Equivalent Dose (NED) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moataz M Emara | Contact | +201064048848 | mm.emara@mans.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Moataz M Emara | Mansoura University Hospital | Principal Investigator |
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Unidentified individual patients' data will be available with the prinicpal investigator on reasonable request after approval by the local IRB.
within 5 years after the study
Undecided
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Randomized controlled superiority trial
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The outcome assessor will be nurses - not invovled in the study - will be unware about the study drug.
| Standard of Care | Drug | This group will receive conventional treatment according to the SSC 2021 guidelines. This group will receive vasopressin as the second line after NE and will not receive DEX. |
|
|
mean NED over the first three days after enrolment or death, whichever comes first; the NED of epinephrine will be estimated as a 1:1 ratio
| over the first three days after enrolment or death |
| Duration of vasopressor infusion in survivors | Duration in hours from the start of the vasopressor (NE or vasopressin) infusion till the time of discontinuation. | through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days |
| Initiation of invasive mechanical ventilation (IMV) | incidence of IMV | through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days |
| Duration of IMV | duratioin in hours | through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days |
| Early acute kidney injury (AKI) | AKI according to the KDIGO guidelines 2012 | within 48 hours |
| Late acute kidney injury (AKI) | AKI according to the KDIGO guidelines 2012 | between 48 hours and 7 days |
| Acute Physiology and Chronic Health Evaluation (APACHE-II) | As a score on MedCalc | on the 3rd day after enrollment |
| Simplified Acute Physiology Score (SAPS) II score | As a score on MedCalc | on the 3rd day after enrollment |
| ICU length of stay | duration in days in survivors | during hospitalization period on average 90 days |
| Hospital length of stay | duration in days in survivors | during hospitlaization period on average 90 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |