Dexmedetomidine and Vasopressin (DEX-PRESSIN) for Reducing In-hospital Mortality in Septic Shock Patients: A Protocol for Randomized Controlled Trial (DecatSepsis-2)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Mansoura University
- Enrollment
- 260
- Primary Endpoint
- in-hospital mortality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcome assessor will be nurses - not invovled in the study - will be unware about the study drug.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
DEX-PRESSIN
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.
Intervention: DEX-PRESSIN (Drug)
Standard-of-care group
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.
Intervention: Standard of Care (Drug)
Outcomes
Primary Outcomes
in-hospital mortality
Time Frame: throughout the hospitalization period on average 90 days.
All-cause inhospital mortality as a binary outcome
Secondary Outcomes
- Duration of vasopressor infusion in survivors(through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days)
- Initiation of invasive mechanical ventilation (IMV)(through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days)
- Hospital length of stay(during hospitlaization period on average 90 days)
- survival analysis(through out the hospitalization period or 28 days after inclusion if discharged from hosptia; before 28 days)
- Norepinephrine Equivalent Dose (NED)(over the first three days after enrolment or death)
- Duration of IMV(through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days)
- Early acute kidney injury (AKI)(within 48 hours)
- Late acute kidney injury (AKI)(between 48 hours and 7 days)
- Acute Physiology and Chronic Health Evaluation (APACHE-II)(on the 3rd day after enrollment)
- Simplified Acute Physiology Score (SAPS) II score(on the 3rd day after enrollment)
- ICU length of stay(during hospitalization period on average 90 days)