Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302998
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-25
Brief Title:
Dexmedetomidine and Vasopressin in Septic Shock
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Dexmedetomidine and Vasopressin DEX-PRESSIN for Reducing In-hospital Mortality in Septic Shock Patients A Protocol for Randomized Controlled Trial DecatSepsis-2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DecatSepsis-2
Brief 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 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 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
The main outcomes of the study are in-hospital mortality norepinephrine equivalent dose ICU scores and inflammatory markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None