Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

NCT ID: NCT05283083

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-25
• Study Completion Date: 2023-03-01

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.

Detailed Description

During septic shock, acute stress response includes neural and humoral autonomic flaring, which tend to be beneficial in the short term. Once shock occurs, it is a failure of the compensation trial. In addition, chronic autonomic stimulation risks myocardial injury, immunosuppression, insulin resistance, and thrombo-embolic tendency.

The investigators hypothesized that dacatecholaminisation with dexmedetomidine - as calibrated by heart rate control - would reduce the in-hospital mortality in septic shock, whether the patient is mechanically ventilated or not. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexmedetomidine

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:

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Usual care without dexmedetomidine infusion

The patients in this group will receive the usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

Other Intervention Names

Precedex, Dexdor, Dexdomitor, Sileo

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• Patient refusal or inability to obtain consent
• Failure of hemodynamic stabilization or hemoglobin < 7 gm/dl at time of inclusion
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moataz M Emara, MD, EDAIC

Role: STUDY_DIRECTOR

Mansoura University Faculty of Medicine

Locations

Mansoura University Hospitals

Al Mansurah, Aldakahlia, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 39004217 (View on PubMed)

Other Identifiers

MS.22.02.1889

Identifier Type: -

Identifier Source: org_study_id