Dexmedetomidine and Vasopressin in Septic Shock (DecatSepsis-2)

Mansoura University

Status and phase: Not yet enrolling; Phase 2

Conditions: Septic Shock; Sepsis

Treatments: Drug: Standard of Care; Drug: DEX-PRESSIN

Study type: Interventional

Funder types: Other

Identifiers

NCT06302998

MS.111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

DEX-PRESSIN

Experimental group

Description:

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.

Treatment:

Drug: DEX-PRESSIN

Standard-of-care group

Active Comparator group

Description:

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.

Treatment:

Drug: Standard of Care