Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-01-01 @ 10:30 AM
Study NCT ID:
NCT03716895
Status:
UNKNOWN
Last Update Posted:
2018-10-23
First Post:
2018-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Septic Shock Complications
Sponsor:
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Organization:
Study Overview
Official Title:
Identifying Risk Factors for Complications in Severe Septic Shock
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
Adults older than 18 years old, admitted to the ICU with a Severe Septic Shock, requiring Norepinephrine at more than 0.25mcg/kg/min, who have signed informed consent form, will be consecutively included, from december 2018 to december 2019.
The primary goal is to look for risk factors associated with an increased in lactate clearance
Secondary goals are the following:
1. To look for risk factors associated with an increase risk of Hospital and ICU length of stay.
2. To look for risk factors associated with an increase risk of Acute Kidney Injury.
3. To look for risk factors associated with a decrease in days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy.
4. To look for risk factors associated with a decrease in Ventilator-free days.
5. To look for risk factors associated with a decrease in Vasopressor-free days.
6. To look for risk factors associated with an increase risk of in-hospital mortality.
7. To look for risk factors associated with an increase risk of Myocardial Infarction and myocardial injury.
8. To look for risk factors associated with an increase risk of Acute Respiratory Distress Syndrome.
9. To compare and validate different risk scores in our cohort.
The primary goal is to look for risk factors associated with an increased in lactate clearance
Secondary goals are the following:
1. To look for risk factors associated with an increase risk of Hospital and ICU length of stay.
2. To look for risk factors associated with an increase risk of Acute Kidney Injury.
3. To look for risk factors associated with a decrease in days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy.
4. To look for risk factors associated with a decrease in Ventilator-free days.
5. To look for risk factors associated with a decrease in Vasopressor-free days.
6. To look for risk factors associated with an increase risk of in-hospital mortality.
7. To look for risk factors associated with an increase risk of Myocardial Infarction and myocardial injury.
8. To look for risk factors associated with an increase risk of Acute Respiratory Distress Syndrome.
9. To compare and validate different risk scores in our cohort.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: