Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473844
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-19
Brief Title:
Efficacy of SGLT2 Inhibitors in Adults With Sepsis
Sponsor:
Hospital Authority Hong Kong
Organization:
Hospital Authority Hong Kong
Study Overview
Official Title:
Efficacy and Safety of Sodium-Glucose Cotransporter 2 Inhibitors in Adults With Sepsis A Feasibility Study for a Multicenter Double-Blind Randomized Placebo-Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Goal of this clinical trial is to examine the safety and efficacy of SGLT2 inhibitors on the clinical outcomes in patients with sepsis Main study outcomes are as follows
i Primary objective is to examine the efficacy and safety of SGLT2 inhibitors on clinical outcomes in patients with sepsis
ii Secondary objective is to examine the effect of SGLT2 inhibitors on inflammatory markers in patients with sepsis
i Primary objective is to examine the efficacy and safety of SGLT2 inhibitors on clinical outcomes in patients with sepsis
ii Secondary objective is to examine the effect of SGLT2 inhibitors on inflammatory markers in patients with sepsis
Detailed Description:
Sepsis is a leading epidemic in the world affecting an estimated 489 million individuals annually Patients who develop consequential organ failure requiring admission to the intensive care unit ICU has a mortality of up to 42 In Hong Kong sepsis was the second most common cause of ICU admission accounting for 169 of the 14068 patient admissions in 2018 Sepsis has remained as one of the top 10 leading causes of death in Hong Kong in the past decade
Recent randomized controlled trials evaluating various therapies in sepsis have not yielded encouraging results Targeted therapeutic options including adjunctive glucocorticoid therapy intravenous vitamin C and sepsis bundles have not been associated with improved clinical outcomes in patients with sepsis Administration of antibiotics for source control has remained as the only treatment proven effective in sepsis for two decades There is an urgent unmet need to identify therapies that may modulate the adverse outcomes of sepsis
Sodium-glucose cotransporter-2 SGLT2 inhibitors are a class of medication that reduces reabsorption of glucose from the kidneys by modulating the sodium-glucose cotransporter in the renal tubules Although originally developed as a drug for type 2 diabetes subsequent large randomized clinical trials have firmly established the clinical efficacy of SGLT2 inhibitors in improving cardiovascular and renal outcomes irrespective of diabetes status Patients who received SGLT2 inhibitors had a 32 relative risk reduction in all-cause mortality 40 reduction in adverse renal outcomes and 30 reduction in hospitalization for heart failure compared with placebo
The investigators hypothesize that SGLT2 inhibitors as compared with placebo will improve clinical outcomes of patients with sepsis who are receiving standard care
i The primary objective is to examine the efficacy and safety of SGLT2 inhibitors on clinical outcomes in patients with sepsis
ii The secondary objective is to examine the effect of SGLT2 inhibitors on inflammatory markers in patients with sepsis
iii The tertiary objective is to examine the feasibility of conducting a multicenter double-blind randomized placebo-controlled trial in the ICUs of Hong Kong
Adult patients age18 years with new onset sepsis and admitted to the ICU will be considered for recruitment based on the study inclusionexclusion criteria Eligible subjects will be randomly assigned to the intervention group or the control group in a 11 ratio In the intervention group the SGLT2 inhibitor empagliflozin 10mg orally daily will be given in addition to standard care until hospital discharge In the control group a placebo tablet once orally daily will be given in addition to standard care until hospital discharge All patients will be followed up daily until hospital discharge or transfer to another facility Blood samples will be collected and sent for an assay that measures the levels of key inflammatory markers
Recent randomized controlled trials evaluating various therapies in sepsis have not yielded encouraging results Targeted therapeutic options including adjunctive glucocorticoid therapy intravenous vitamin C and sepsis bundles have not been associated with improved clinical outcomes in patients with sepsis Administration of antibiotics for source control has remained as the only treatment proven effective in sepsis for two decades There is an urgent unmet need to identify therapies that may modulate the adverse outcomes of sepsis
Sodium-glucose cotransporter-2 SGLT2 inhibitors are a class of medication that reduces reabsorption of glucose from the kidneys by modulating the sodium-glucose cotransporter in the renal tubules Although originally developed as a drug for type 2 diabetes subsequent large randomized clinical trials have firmly established the clinical efficacy of SGLT2 inhibitors in improving cardiovascular and renal outcomes irrespective of diabetes status Patients who received SGLT2 inhibitors had a 32 relative risk reduction in all-cause mortality 40 reduction in adverse renal outcomes and 30 reduction in hospitalization for heart failure compared with placebo
The investigators hypothesize that SGLT2 inhibitors as compared with placebo will improve clinical outcomes of patients with sepsis who are receiving standard care
i The primary objective is to examine the efficacy and safety of SGLT2 inhibitors on clinical outcomes in patients with sepsis
ii The secondary objective is to examine the effect of SGLT2 inhibitors on inflammatory markers in patients with sepsis
iii The tertiary objective is to examine the feasibility of conducting a multicenter double-blind randomized placebo-controlled trial in the ICUs of Hong Kong
Adult patients age18 years with new onset sepsis and admitted to the ICU will be considered for recruitment based on the study inclusionexclusion criteria Eligible subjects will be randomly assigned to the intervention group or the control group in a 11 ratio In the intervention group the SGLT2 inhibitor empagliflozin 10mg orally daily will be given in addition to standard care until hospital discharge In the control group a placebo tablet once orally daily will be given in addition to standard care until hospital discharge All patients will be followed up daily until hospital discharge or transfer to another facility Blood samples will be collected and sent for an assay that measures the levels of key 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