Clinical trial NCT06302998: Dexmedetomidine and Vasopressin in Septic Shock
Official title: Dexmedetomidine and Vasopressin (DEX-PRESSIN) for Reducing In-hospital Mortality in Septic Shock Patients: A Protocol for Randomized Controlled Trial (DecatSepsis-2)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Sepsis
Septic Shock
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled superiority trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients who develop septic shock in whom a vasopressor is initiated to maintain a mean arterial blood pressure (MAP) of ≥65 mmHg in the presence 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 g/dL at the time of inclusion
* Severe cardiac dysfunction \[i.e., ejection fraction (EF) \<30%\]
* History of heart block or patient on pacemaker
* Severe valvular heart disease
* Chronic liver disease (Child-Pugh classification C)
* Pregnancy
* Patients with traumatic brain injury

Primary outcomes:
measure: in-hospital mortality
timeFrame: throughout the hospitalization period on average 90 days.
Secondary outcomes:
measure: survival analysis
timeFrame: through out the hospitalization period or 28 days after inclusion if discharged from hosptia; before 28 days
measure: Norepinephrine Equivalent Dose (NED)
timeFrame: over the first three days after enrolment or death
measure: Duration of vasopressor infusion in survivors
timeFrame: through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days
measure: Initiation of invasive mechanical ventilation (IMV)
timeFrame: through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days
measure: Duration of IMV
timeFrame: through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days
measure: Early acute kidney injury (AKI)
timeFrame: within 48 hours
measure: Late acute kidney injury (AKI)
timeFrame: between 48 hours and 7 days
measure: Acute Physiology and Chronic Health Evaluation (APACHE-II)
timeFrame: on the 3rd day after enrollment
measure: Simplified Acute Physiology Score (SAPS) II score
timeFrame: on the 3rd day after enrollment
measure: ICU length of stay
timeFrame: during hospitalization period on average 90 days
measure: Hospital length of stay
timeFrame: during hospitlaization period on average 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura University Hospital
name: Moataz M Emara
role: PRINCIPAL_INVESTIGATOR
References: