Dexmedetomidine in Modifying Immune Paralysis In Patient With Septic Shock

NCT03989609 | Completed Phase 2

• 1 other identifier: N-5-2019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Change in CD42/CD14

  Expression of CD42/CD14 will be measured by flow cytometry

  24 hours after start of study drugs infusion

Secondary Outcomes (5)

• effect on HLA-DR/CD14

  Baseline before start of drug then 6, 12 and 24 hour after drug

• TNFα

  Baseline before start of drug then 6, 12 and 24 hour after drug

• IL10

  Baseline before start of drug then 6, 12 and 24 hour after drug

• KIM-1 level

  Baseline before start of drug and 24 hour after drug

• number of participants that will die within 28 days

  within 28 dyas

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

patients will receive dexmedetomidine as sedative

Drug: Dexmedetomidine Injection [Precedex]

Midazolam

ACTIVE COMPARATOR

patients will receive midazolam as sedative

Drug: Midazolam

Interventions

Dexmedetomidine Injection [Precedex] 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,

Dexmedetomidine Group

Midazolam 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).

Midazolam

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy Hospital , Faculty of Medicine

Cairo, Egypt

Location

Related Publications (5)

• Biswas SK, Lopez-Collazo E. Endotoxin tolerance: new mechanisms, molecules and clinical significance. Trends Immunol. 2009 Oct;30(10):475-87. doi: 10.1016/j.it.2009.07.009. Epub 2009 Sep 24.

  PMID: 19781994 BACKGROUND

• Yeaman MR. Platelets in defense against bacterial pathogens. Cell Mol Life Sci. 2010 Feb;67(4):525-44. doi: 10.1007/s00018-009-0210-4. Epub 2009 Dec 15.

  PMID: 20013024 BACKGROUND

• Miranda ML, Balarini MM, Bouskela E. Dexmedetomidine attenuates the microcirculatory derangements evoked by experimental sepsis. Anesthesiology. 2015 Mar;122(3):619-30. doi: 10.1097/ALN.0000000000000491.

  PMID: 25313879 BACKGROUND

• Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

  PMID: 28101605 BACKGROUND

• Elayashy M, Elsayed EA, Mukhtar AM, Kasem S, Elmetwally SA, Habib S, Abdelfattah W, Ghaith D, Hussein A. Role of dexmedetomidine in modifying immune paralysis in patients with septic shock: randomized controlled trial. Intensive Care Med Exp. 2023 Sep 4;11(1):59. doi: 10.1186/s40635-023-00542-2.

  PMID: 37665397 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Sepsis; 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; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ahmed Mohamed Mukhtar, M,D

  kasralainy faculty of medicine, Cairo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: June 20, 2019
• Primary Completion: February 20, 2020
• Study Completion: August 20, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)