Dexmedetomidine and Vasopressin in Septic Shock

Phase 2

Not yet recruiting

• Conditions: Sepsis; Septic Shock
• Interventions: Drug: DEX-PRESSIN; Drug: Standard of Care

• Registration Number: NCT06302998
• Lead Sponsor: Mansoura University

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 Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-03-08
• Last Update Submitted: 2024-03-08
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Study Start: 2024-06
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEX-PRESSIN	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.
Standard-of-care group	Standard of Care	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.

Primary Outcome Measures

Name	Time	Method
in-hospital mortality	throughout the hospitalization period on average 90 days.	All-cause inhospital mortality as a binary outcome

Secondary Outcome Measures

Name	Time	Method
Duration of vasopressor infusion in survivors	through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days	Duration in hours from the start of the vasopressor (NE or vasopressin) infusion till the time of discontinuation.
Initiation of invasive mechanical ventilation (IMV)	through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days	incidence of IMV
survival analysis	through out the hospitalization period or 28 days after inclusion if discharged from hosptia; before 28 days	time to die using Kaplan Mier Curve
Norepinephrine Equivalent Dose (NED)	over the first three days after enrolment or death	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
Duration of IMV	through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days	duratioin in hours
Early acute kidney injury (AKI)	within 48 hours	AKI according to the KDIGO guidelines 2012
Late acute kidney injury (AKI)	between 48 hours and 7 days	AKI according to the KDIGO guidelines 2012
Acute Physiology and Chronic Health Evaluation (APACHE-II)	on the 3rd day after enrollment	As a score on MedCalc
Simplified Acute Physiology Score (SAPS) II score	on the 3rd day after enrollment	As a score on MedCalc
ICU length of stay	during hospitalization period on average 90 days	duration in days in survivors
Hospital length of stay	during hospitlaization period on average 90 days	duration in days in survivors