Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481410
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-21
Brief Title:
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
First Affiliated Hospital of Zhejiang University
Study Overview
Official Title:
Exploratory Study on the Efficacy and Safety of Methylene Blue in Treating Severe Septic Shock Patients A Prospective Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The goal of this clinical trial is to investigate whether methylene blue injection can safely and effectively improve the survival rate of patients with severe septic shock shorten the duration of norepinephrine use reduce the dosage of vasopressors promptly correct hemodynamics and improve tissue perfusion and organ function impairment
Detailed Description:
Researchers will compare methylene blue to a placebo a look-alike substance that contains no drug to see if methylene blue works to treat severe septic shock
Participants will
Administer a loading dose of 25 mgkg via micro-pump over 15 minutes followed by a maintenance infusion at a rate of 025 mgkghour for 12 hours or until norepinephrine has been continuously discontinued for 4 hours whichever comes first If norepinephrine needs to be increased to 025 μgkgmin before the 12-hour period ends continue using methylene blue until the 12-hour infusion is completed
Primary Study Endpoint
- 28-day all-cause mortality rate starting from the diagnosis of septic shock
Secondary Study Endpoints
Time from the start to the discontinuation of norepinephrine after the diagnosis of septic shock
Total dose of norepinephrine used from enrollment to 72 hours
Number of days without norepinephrine within 28 days
Duration of mechanical ventilation
Rate of CRRT Continuous Renal Replacement Therapy
Length of ICU stay
Total hospital stay
Record the following indicators before methylene blue intervention and at 24 hours 72 hours and 5 days after the intervention
Highest serum lactate level
Lowest mean arterial pressure
Alanine aminotransferase ALT
Total bilirubin
Creatinine
Oxygenation index PF ratio
Creatine kinase-MB CK-MB
Troponin I TNI
Systemic vascular resistance index SVRI
Participants will
Administer a loading dose of 25 mgkg via micro-pump over 15 minutes followed by a maintenance infusion at a rate of 025 mgkghour for 12 hours or until norepinephrine has been continuously discontinued for 4 hours whichever comes first If norepinephrine needs to be increased to 025 μgkgmin before the 12-hour period ends continue using methylene blue until the 12-hour infusion is completed
Primary Study Endpoint
- 28-day all-cause mortality rate starting from the diagnosis of septic shock
Secondary Study Endpoints
Time from the start to the discontinuation of norepinephrine after the diagnosis of septic shock
Total dose of norepinephrine used from enrollment to 72 hours
Number of days without norepinephrine within 28 days
Duration of mechanical ventilation
Rate of CRRT Continuous Renal Replacement Therapy
Length of ICU stay
Total hospital stay
Record the following indicators before methylene blue intervention and at 24 hours 72 hours and 5 days after the intervention
Highest serum lactate level
Lowest mean arterial pressure
Alanine aminotransferase ALT
Total bilirubin
Creatinine
Oxygenation index PF ratio
Creatine kinase-MB CK-MB
Troponin I TNI
Systemic vascular resistance index SVRI
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