Dexmedetomidine and Vasopressin in Septic Shock

NCT06302998 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: MS.111
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (1)

• in-hospital mortality

  All-cause inhospital mortality as a binary outcome

  throughout the hospitalization period on average 90 days.

Secondary Outcomes (11)

• 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 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

• Duration of IMV

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

Study Arms (2)

DEX-PRESSIN

EXPERIMENTAL

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.

Drug: DEX-PRESSIN

Standard-of-care group

ACTIVE COMPARATOR

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.

Drug: Standard of Care

Interventions

DEX-PRESSIN DRUG

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.

DEX-PRESSIN

Standard of Care DRUG

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.

Also known as: Control group

Standard-of-care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patient refusal or inability to obtain consent
• 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

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Standard of Care; Control Groups

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Moataz M Emara

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moataz M Emara

CONTACT

+201064048848; mm.emara@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be nurses - not invovled in the study - will be unware about the study drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled superiority trial

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 12, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: within 5 years after the study
• Access Criteria: Undecided