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Septic ShockPhase 2DECATSepsisNCT05283083

Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

A Phase 2 study testing Dexmedetomidine in people with Septic Shock and Sepsis, run by Mansoura University 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock, Sepsis
What is being tested?
Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
25 Mar 2022to 1 Mar 2023
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

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Mansoura University Hospitals

    Al Mansurah, Aldakahlia, 35516

Other trials in Egypt

About this study

Official title: Decatecholaminisation With Dexmedetomidine for Reduction of Mortality in Septic Shock: A Randomized Clinical Trial

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.

Read the 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
Being tested
Dexmedetomidine
Keywords
dexmedetomidine, randomized controlled trial
Medical subject headings
Shock, Septic, Sepsis

What participants receive

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

  • DexmedetomidineDrug

    Also called Precedex, Dexdor, Dexdomitor, Sileo

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

Study groups in NCT05283083
Study groupRoleWhat they receive
DexmedetomidineExperimentalPatients 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:
Receives: Drug: Dexmedetomidine
Usual care without dexmedetomidine infusionNo interventionThe patients in this group will receive the usual care.

What is being measured

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

  1. In-hospital mortality

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

    Measured: Through study completion, an average of 3 months

Secondary outcomes (7)

  1. Norepinephrine equivalent dose (NED)

    reported as the average of the serial measurements; the NED of epinephrine will be estimated as 1:1 ratio, reported as mcg/kg/min (Shruti Goradia et al, 2021)

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

  2. Need for epinephrine infusion

    Categorical variable (as yes/no outcome)

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

  3. Heart rate (HR) beat per minute

    reported as the average of the serial measurements

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

  4. Mean arterial blood pressure (MAP) mmHg

    reported as the average of the serial measurements

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

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

    Categorical variable (as yes/no outcome)

    Measured: Through study completion, an average of 3 months

  6. Early acute kidney injury

    Categorical variable (as yes/no outcome) - as defined by Khwaja, A., 2012. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clinical Practice, 120(4), pp.c179-c184.

    Measured: 48 hours after ICU admission in previously normal kidney function

  7. Late acute kidney injury

    Categorical variable (as yes/no outcome) - as defined by the Khwaja, A., 2012. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clinical Practice, 120(4), pp.c179-c184.

    Measured: 7 days after ICU admission in previously normal kidney function

Timeline

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

  1. First posted16 Mar 2022
  2. Study start25 Mar 2022
  3. Primary completion1 Feb 2023
  4. Study completion1 Mar 2023

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
Model description
An open label randomized controlled trial
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05283083
Sponsor's protocol ID
MS.22.02.1889
Acronym
DECATSepsis
Status last verified
May 2023
First submitted
28 Feb 2022
Last updated
6 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39004217

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexmedetomidine in people with Septic Shock and Sepsis, run by Mansoura University 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 7 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 6 May 2023. 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?

In-hospital mortality (time frame: Through study completion, an average of 3 months). 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 NCT05283083, which also lists 1 linked publication.

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 6 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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