SepsisPhase 2DecatSepsis-2NCT06302998
Dexmedetomidine and Vasopressin in Septic Shock
A Phase 2 study testing DEX-PRESSIN in people with Sepsis and Septic Shock, run by Mansoura University.
Trial summary
Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- DEX-PRESSIN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jan 2026
- 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 patients who develop septic shock in whom a vasopressor is initiated to maintain a mean arterial blood pressure (MAP) of ≥65 mmHg in the presence 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 g/dL at the time of inclusion
- Severe cardiac dysfunction [i.e., ejection fraction (EF) <30%]
- History of heart block or patient on pacemaker
- Severe valvular heart disease
- Chronic liver disease (Child-Pugh classification C)
- Pregnancy
- Patients with traumatic brain injury
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Dexmedetomidine and Vasopressin (DEX-PRESSIN) for Reducing In-hospital Mortality in Septic Shock Patients: A Protocol for Randomized Controlled Trial (DecatSepsis-2)
Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. The investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients.
The investigators of the current study will use DEXPRESSIN in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality.
Read the detailed description
The investigator will include 260 patients with septic shock. The study will compare the use of vasopressin as the first-line vasopressor in septic shock in addition to the dexmedetomidine infusion as in the DecatSepsis trial versus the standard of care. The standard of care is guided by the Surviving Sepsis campaign in 2021.
The main outcomes of the study are in-hospital mortality, norepinephrine equivalent dose, ICU scores, and inflammatory markers.
- Conditions
- Sepsis, Septic Shock
- Being tested
- DEX-PRESSIN, Standard of Care
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEX-PRESSINDrug
This group will receive vasopressin as the first-line vasopressor. DEX will be started after hemodynamic stabilization if the heart rate is >90 beats per minute (bpm). NE infusion will be the second-line vasoactive drug.
Standard of CareDrug
Also called Control group
This group will receive conventional treatment according to the SSC 2021 guidelines. This group will receive vasopressin as the second line after NE and will not receive DEX.
| Study group | Role | What they receive |
|---|---|---|
| DEX-PRESSIN | Experimental | This group will receive vasopressin as the first-line vasopressor. DEX will be started after hemodynamic stabilization if the heart rate is >90 beats per minute (bpm). NE infusion will be the second-line vasoactive drug. Receives: Drug: DEX-PRESSIN |
| Standard-of-care group | Active comparator | This group will receive conventional treatment according to the Surviving Sepsis Campaign 2021 guidelines. This group will receive vasopressin as the second line after NE and will not receive dexmedetomidine. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
All-cause inhospital mortality as a binary outcome
Measured: throughout the hospitalization period on average 90 days.
Secondary outcomes (11)
survival analysis
time to die using Kaplan Mier Curve
Measured: through out the hospitalization period or 28 days after inclusion if discharged from hosptia; before 28 days
Norepinephrine Equivalent Dose (NED)
mean NED over the first three days after enrolment or death, whichever comes first; the NED of epinephrine will be estimated as a 1:1 ratio
Measured: over the first three days after enrolment or death
Duration of vasopressor infusion in survivors
Duration in hours from the start of the vasopressor (NE or vasopressin) infusion till the time of discontinuation.
Measured: through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days
Initiation of invasive mechanical ventilation (IMV)
incidence of IMV
Measured: through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days
Duration of IMV
duratioin in hours
Measured: through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days
Early acute kidney injury (AKI)
AKI according to the KDIGO guidelines 2012
Measured: within 48 hours
Late acute kidney injury (AKI)
AKI according to the KDIGO guidelines 2012
Measured: between 48 hours and 7 days
Acute Physiology and Chronic Health Evaluation (APACHE-II)
As a score on MedCalc
Measured: on the 3rd day after enrollment
Simplified Acute Physiology Score (SAPS) II score
As a score on MedCalc
Measured: on the 3rd day after enrollment
ICU length of stay
duration in days in survivors
Measured: during hospitalization period on average 90 days
Hospital length of stay
duration in days in survivors
Measured: during hospitlaization period on average 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomized controlled superiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moataz M Emara, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302998
- Sponsor's protocol ID
- MS.111
- Acronym
- DecatSepsis-2
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified individual patients' data will be available with the prinicpal investigator on reasonable request after approval by the local IRB.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine and Vasopressin (DEX-PRESSIN) for Reducing In-hospital Mortality in Septic Shock Patients: A Protocol for Randomized Controlled Trial (DecatSepsis-2)
- ClinicalTrials.gov ID
- NCT06302998
- Acronym / sponsor ID
- DecatSepsis-2 / MS.111
- Conditions
- Sepsis, Septic Shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. The investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients.
The investigators of the current study will use DEXPRESSIN in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality.
Detailed description
The investigator will include 260 patients with septic shock. The study will compare the use of vasopressin as the first-line vasopressor in septic shock in addition to the dexmedetomidine infusion as in the DecatSepsis trial versus the standard of care. The standard of care is guided by the Surviving Sepsis campaign in 2021.
The main outcomes of the study are in-hospital mortality, norepinephrine equivalent dose, ICU scores, and inflammatory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled superiority trial
| Arm | Type | Receives |
|---|---|---|
| DEX-PRESSIN | Experimental | Drug: DEX-PRESSINThis group will receive vasopressin as the first-line vasopressor. DEX will be started after hemodynamic stabilization if the heart rate is >90 beats per minute (bpm). NE infusion will be the second-line vasoactive drug. |
| Standard-of-care group | Active comparator | Drug: Standard of CareThis group will receive conventional treatment according to the Surviving Sepsis Campaign 2021 guidelines. This group will receive vasopressin as the second line after NE and will not receive dexmedetomidine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who develop septic shock in whom a vasopressor is initiated to maintain a mean arterial blood pressure (MAP) of ≥65 mmHg in the presence of sepsis (≥2 SIRS criteria plus suspicion or confirmation of infection).
Key exclusion criteria (8 listed)
- Patient refusal or inability to obtain consent
- Failure of hemodynamic stabilization or hemoglobin <7 g/dL at the time of inclusion
- Severe cardiac dysfunction [i.e., ejection fraction (EF) <30%]
- History of heart block or patient on pacemaker
- Severe valvular heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEX-PRESSINThis group will receive vasopressin as the first-line vasopressor. DEX will be started after hemodynamic stabilization if the heart rate is >90 beats per minute (bpm). NE infusion will be the second-line vasoactive drug. | Drug | DEX-PRESSIN |
| Standard of CareAlso: Control groupThis group will receive conventional treatment according to the SSC 2021 guidelines. This group will receive vasopressin as the second line after NE and will not receive DEX. | Drug | Standard-of-care group |
Primary outcome
in-hospital mortality
Time frame: throughout the hospitalization period on average 90 days.
All-cause inhospital mortality as a binary outcome
11 secondary outcomes
survival analysis
Time frame: through out the hospitalization period or 28 days after inclusion if discharged from hosptia; before 28 days
Norepinephrine Equivalent Dose (NED)
Time frame: over the first three days after enrolment or death
Duration of vasopressor infusion in survivors
Time frame: through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days
Initiation of invasive mechanical ventilation (IMV)
Time frame: through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days
Duration of IMV
Time frame: through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days
Early acute kidney injury (AKI)
Time frame: within 48 hours
Late acute kidney injury (AKI)
Time frame: between 48 hours and 7 days
Acute Physiology and Chronic Health Evaluation (APACHE-II)
Time frame: on the 3rd day after enrollment
Simplified Acute Physiology Score (SAPS) II score
Time frame: on the 3rd day after enrollment
ICU length of stay
Time frame: during hospitalization period on average 90 days
Hospital length of stay
Time frame: during hospitlaization period on average 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Yes. Unidentified individual patients' data will be available with the prinicpal investigator on reasonable request after approval by the local IRB.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moataz M Emara principal investigator
Mansoura University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DEX-PRESSIN in people with Sepsis and Septic Shock, run by Mansoura University.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moataz M Emara (+201064048848, mm.emara@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: throughout the hospitalization period on average 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.