Dexmedetomidine and Vasopressin in Septic Shock

Phase 2Not Yet RecruitingNCT06302998

Mansoura University260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

260

Conditions

Sepsis Septic Shock

Interventions

DEX-PRESSINDRUG

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 CareDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

in-hospital mortality

All-cause inhospital mortality as a binary outcome

Time frame: throughout the hospitalization period on average 90 days.

Secondary Outcomes

survival analysis

time to die using Kaplan Mier Curve

Time frame: through out the hospitalization period or 28 days after inclusion if discharged from hosptia; before 28 days

Norepinephrine Equivalent Dose (NED)

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

Time frame: 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.

Time frame: 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

Time frame: through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days

Duration of IMV

duratioin in hours

Time frame: 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

Time frame: within 48 hours

Central Contacts

Moataz M Emara

CONTACT

+201064048848 mm.emara@mans.edu.eg

Data from ClinicalTrials.gov

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