Dexmedetomidine in Modifying Immune Paralysis In Patient With Septic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-20

Study Completion Date

2021-08-20

Brief Summary

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in this study the investigators aim to assess the role of using dexmedetomidine as sedative in septic shock patients in comparison with midazolam. The investigators aim to assess the effect on immune response and inflammatory mediators and effect on vasopressors.

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Detailed Description

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Sedation protocol All patients will receive analgesia with fentanyl at ﬁxed dose of 0.5 µg.kg.hr-1. Each patient will receive the study drug within 6 hours after ICU admission. Depth of sedation will be assessed using Richmond Agitation and Sedation Scale (RASS) scores (6), which range from -5 (unarousable) to +4 (combative). Study treatments will be infused without loading dose. Group I patients will have dexmedetomidine (4 µg.mL-1) and group II patients will have midazolam (0.33 mg.mL-1). Both drugs will be prepared in 0.9% sodium chloride in 50-mL syringe. Both the agents will be titrated to maintain the RASS in a range of -3 to -1. Dexmedetomidine infusion will be started at 0.1 µg.kg-1.hr-1 and will be adjusted by 0.1 µg.kg-1.h-1 to a maximum of 0.5 µg/kg/h, while midazolam will be started at 1 mg.h-1 (3 mL.hr-1) and adjusted by 1 mg.h-1 to a maximum of 5 mg.h-1 (15 mL.h-1). All infusions will be adjusted by increments of 3 mL/hr-1. Patients in either group not adequately sedated by study drug titration will receive a bolus dose of fentanyl 0.5-1 µg.kg. Assessment of RASS score will be performed every 2 hours and prior to any dose of rescue therapy. The study drugs will be infused for 24 hours and after that the choice of sedation will be determined according to preference of attending physician.

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine Group

patients will receive dexmedetomidine as sedative

Group Type EXPERIMENTAL

Dexmedetomidine Injection [Precedex]

Intervention Type DRUG

Dexmedetomidine infusion will be started at 0.1 µg.kg-1.hr-1 and will be adjusted by 0.1 µg.kg-1.h-1 to a maximum of 0.5 µg/kg/h,

Midazolam

patients will receive midazolam as sedative

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

midazolam will be started at 1 mg.h-1 (3 mL.hr-1) and adjusted by 1 mg.h-1 to a maximum of 5 mg.h-1 (15 mL.h-1).

Interventions

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Dexmedetomidine Injection [Precedex]

Dexmedetomidine infusion will be started at 0.1 µg.kg-1.hr-1 and will be adjusted by 0.1 µg.kg-1.h-1 to a maximum of 0.5 µg/kg/h,

Intervention Type DRUG

Midazolam

midazolam will be started at 1 mg.h-1 (3 mL.hr-1) and adjusted by 1 mg.h-1 to a maximum of 5 mg.h-1 (15 mL.h-1).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age more than 18 years old
* All mechanically ventilated patients who will be clinically suspected of having septic shock defined by infusion of at least one vasopressor and lactate \> 2.0 mmol/l (5)

Exclusion Criteria

* Age \< 18 years old
* Pregnant patient
* Source of sepsis not controlled
* Acute hepatitis or severe liver disease (Child-Pugh class C)
* Left ventricular ejection fraction less than 30%
* Heart rate less than 50 beats/min
* Second or third degree heart block
* Systolic pressure \< 90 mmHg despite of infusion of 2 vasopressors.
* Psychological illness or severe cognitive dysfunction
* Patients who are allergic to dexmedetomidine

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No