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Septic ShockPhase 2RODISNCT03989609

Dexmedetomidine in Modifying Immune Paralysis In Patient With Septic Shock

A Phase 2 study testing Dexmedetomidine Injection [Precedex] and Midazolam in people with Septic Shock, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock
What is being tested?
Dexmedetomidine Injection [Precedex] and Midazolam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteEgypt
Study dates
20 Jun 2019to 20 Aug 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Kasr Alainy Hospital , Faculty of Medicine

    Cairo

Other trials in Egypt

About this study

Official title: ROle of Dexmedetomidine in Modifying Immune Paralysis In Patient With Septic Shock: Randomized Controlled Trial (RODIS Trial)

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.

Read the detailed description

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
Septic Shock
Being tested
Dexmedetomidine Injection [Precedex], Midazolam
Medical subject headings
Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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,

  • MidazolamDrug

    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).

Study groups in NCT03989609
Study groupRoleWhat they receive
Dexmedetomidine GroupExperimentalpatients will receive dexmedetomidine as sedative
Receives: Drug: Dexmedetomidine Injection [Precedex]
MidazolamActive comparatorpatients will receive midazolam as sedative
Receives: Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in CD42/CD14

    Expression of CD42/CD14 will be measured by flow cytometry

    Measured: 24 hours after start of study drugs infusion

Secondary outcomes (5)

  1. effect on HLA-DR/CD14

    Expression of HLA-DR/CD14 will be measured by flow cytometry

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

  2. TNFα

    Expression of tumor necrosis factor (TNFα) will be measured by flow cytometry

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

  3. IL10

    Interleukin 10 will be measured by flow cytometry

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

  4. KIM-1 level

    kidney injury molecule 1

    Measured: Baseline before start of drug and 24 hour after drug

  5. number of participants that will die within 28 days

    mortality within 28 days

    Measured: within 28 dyas

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2019
  2. Study start20 Jun 2019
  3. Primary completion20 Feb 2020
  4. Study completion20 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03989609
Sponsor's protocol ID
N-5-2019
Acronym
RODIS
Status last verified
Jul 2022
First submitted
14 Jun 2019
Last updated
19 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19781994

  • 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.

    PubMed 20013024

  • 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.

    PubMed 25313879

  • 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.

    PubMed 28101605

  • 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.

    PubMed 37665397

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexmedetomidine Injection [Precedex] and Midazolam in people with Septic Shock, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in CD42/CD14 (time frame: 24 hours after start of study drugs infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03989609, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.

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