Dexmedetomidine and Vasopressin in Septic Shock

Sepsis Clinical Trial

— DecatSepsis-2  

Official title:

Dexmedetomidine and Vasopressin (DEX-PRESSIN) for Reducing In-hospital Mortality in Septic Shock Patients: A Protocol for Randomized Controlled Trial (DecatSepsis-2)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06302998
• Other study ID #: MS.111
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Mansoura University
• Contact: Moataz M Emara
• Phone: +201064048848
• Email: mm.emara[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: January 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

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