A Phase 2 interventional study of DEX-PRESSIN and Standard of Care in Sepsis and Septic Shock, sponsored by Mansoura University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Mansoura University · Phase 2, Interventional, and Treatment
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.
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's planned enrollment of 260 is above the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: DEX-PRESSIN
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.
Drug: Standard of Care
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.
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.
Also known as: Control group
in-hospital mortality
All-cause inhospital mortality as a binary outcome
Time frame: throughout the hospitalization period on average 90 days.
survival analysis
time to die using Kaplan Mier Curve
Time frame: 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
Time frame: 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.
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)
incidence of IMV
Time frame: through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days
Duration of IMV
duratioin in hours
Time frame: 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
Time frame: within 48 hours
Late acute kidney injury (AKI)
AKI according to the KDIGO guidelines 2012
Time frame: between 48 hours and 7 days
Acute Physiology and Chronic Health Evaluation (APACHE-II)
As a score on MedCalc
Time frame: on the 3rd day after enrollment
Simplified Acute Physiology Score (SAPS) II score
As a score on MedCalc
Time frame: on the 3rd day after enrollment
ICU length of stay
duration in days in survivors
Time frame: during hospitalization period on average 90 days
Hospital length of stay
duration in days in survivors
Time frame: during hospitlaization period on average 90 days
No study locations are listed for this record.
Plan to share: Yes — Unidentified individual patients' data will be available with the prinicpal investigator on reasonable request after approval by the local IRB.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Mansoura University