Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471231
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-14
Brief Title:
Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock
Sponsor:
Azienda Usl di Bologna
Organization:
Azienda Usl di Bologna
Study Overview
Official Title:
Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock
Status:
RECRUITING
Status Verified Date:
2024-05
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:
EVSS
Brief Summary:
The aim of the present study is to verify whether the earlier association of vasopressin and norepinephrine in patients in septic shock determines variations in terms of use of renal function replacement techniques in the first 7 days of hospitalization in Intensive Care compared to patients in whom vasopressin is added only when norepinephrine reaches a higher dose
Detailed Description:
The aim of the present study is to verify whether the earlier association of vasopressin and norepinephrine in patients in septic shock determines variations in terms of use of renal function replacement techniques in the first 7 days of hospitalization in Intensive Care compared to patients in whom vasopressin is added only when norepinephrine reaches a higher dose The study is aimed at patients admitted to the ICU with a diagnosis of septic shock on admission or in the first 24 hours of admission
Patients will be divided and randomized in a 11 ratio through a computer-generated scheme when the dose of norepinephrine administered is 025 mcgkgmin into the following groups
Group A when the norepinephrine dosage is equal to or greater than 025 mcgkgmin in the absence of adequate MAP Mean arterial pressure 65 mmhg vasopressin infusion will be associated with the standard dosage of 03UImin
Group B control the infusion of vasopressin at a dosage of 03 IUmin will be associated if norepinephrine exceeds the dosage of 05 mcgkgmin in the absence of adequate MAP
Patients will be divided and randomized in a 11 ratio through a computer-generated scheme when the dose of norepinephrine administered is 025 mcgkgmin into the following groups
Group A when the norepinephrine dosage is equal to or greater than 025 mcgkgmin in the absence of adequate MAP Mean arterial pressure 65 mmhg vasopressin infusion will be associated with the standard dosage of 03UImin
Group B control the infusion of vasopressin at a dosage of 03 IUmin will be associated if norepinephrine exceeds the dosage of 05 mcgkgmin in the absence of adequate MAP
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?:
None
Is an FDA AA801 Violation?:
None