Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

NCT05283083 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MS.22.02.1889
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to determine whether the infusion of DEX in septic shock can reduce in-hospital mortality, norepinephrine infusion, need and duration for mechanical ventilation, and acute kidney injury without significant adverse events.

Conditions

Septic Shock; Sepsis

Keywords

dexmedetomidine; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  The investigators will review the patient status on discharge from the hospital, alive or dead

  Through study completion, an average of 3 months

Secondary Outcomes (7)

• Norepinephrine equivalent dose (NED)

  over the first 3 days after enrolment or death, which comes first

• Need for epinephrine infusion

  over the first 3 days after enrolment or death, which comes first

• Heart rate (HR) beat per minute

  over the first 3 days after enrolment or death, which comes first

• Mean arterial blood pressure (MAP) mmHg

  over the first 3 days after enrolment or death, which comes first

• Initiation of invasive mechanical ventilation (IMV) in non-ventilated patients

  Through study completion, an average of 3 months

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Patients will receive dexmedetomidine infusion according to the protocol plus the usual care. We will evaluate patients for inclusion in the study after 6 hours on NE infusion, given stabilization of the MAP \> 65 mmHg. In the DEX group, we will commence DEX infusion at the rate of 0.2 mcg.kg-1.h-1 without a loading dose, then titrate DEX infusion to maintain the HR from 60 to 90 bpm. Titration of the DEX infusion rate will not be more than 0.1 mcg.kg-1.h-1 every 30 minutes at any time. The maximum DEX infusion rate will be 0.7 mcg.kg-1.h-1. We aim to continue DEX infusion for 48 hours. After 48 hours of DEX infusion, we will taper the DEX infusion over one hour. According to our protocol, DEX infusion would trigger either STOP events or hemodynamic assessment events:

Drug: Dexmedetomidine

Usual care without dexmedetomidine infusion

NO INTERVENTION

The patients in this group will receive the usual care.

Interventions

Dexmedetomidine DRUG

A highly-selective alpha-2 agonist with sedative, analgesic, and sympatholytic effects.

Also known as: Precedex, Dexdor, Dexdomitor, Sileo

Dexmedetomidine

Eligibility Criteria

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

You may qualify if:

• Adult (≥ 18 years) patients of either sex who develop septic shock with heart rate (HR) \> 90 beats per minute (bpm).
• We choose the definition of septic shock as the start of norepinephrine (NE) infusion to maintain the mean arterial blood pressure (MAP) of ≥ 65 mmHg in a case 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 (Ejection Fraction (EF) \< 30%)
• History of heart block or patient on pacemaker
• Chronic liver Disease (Child-Pugh classification C)
• Severe valvular heart disease
• Pregnancy

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Aldakahlia, 35516, Egypt

Location

Related Publications (1)

• Ezz Al-Regal AR, Ramzy EA, Atia AAA, Emara MM. Dexmedetomidine for Reducing Mortality in Patients With Septic Shock: A Randomized Controlled Trial (DecatSepsis). Chest. 2024 Dec;166(6):1394-1405. doi: 10.1016/j.chest.2024.06.3794. Epub 2024 Jul 14.

  PMID: 39004217 DERIVED

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Moataz M Emara, MD, EDAIC

  Mansoura University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An open label randomized controlled trial

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 16, 2022
• Study Start: March 25, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: will be shared shortly.
• Access Criteria: The anonymously patient data will be available on reasonable request - according to the local IRB approval - from the corresponding author and the central study contact, Moataz Emara at mm.emara@mans.edu.eg or mm.emara@yahoo.com.

Locations

EG (1)