Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531642
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury CEPU-AKI in Hemorrhagic Shock Patients a Prospective Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Trauma AKI PPI
Brief Summary:
The investigators propose a single-center randomized controlled trial to determine whether early initiation of proton pump inhibitor PPI pantoprazole will decrease acute kidney injury AKI for trauma patients presenting with hemorrhagic shock compared to routine timing of initiation of PPI Kidney injury will be assessed by the urinary kidney injury biomarkers and the incidence severity and AKI-free days within first week and major adverse kidney events MAKE at day 30 The specific aims of the study will be achieved by a cohort of 100 patients to receive either earlystudy or routine control administration of pantoprazole for 2 days after the initial injury insult
Detailed Description:
Traumatic injuries account for 10 of all deaths globally and are the leading cause of mortality for trauma patients under 46 in the United States Hemorrhage is the primary cause of death in both civilian and military trauma scenarios worldwide Following hemorrhage and traumatic brain injury organ failure including acute kidney injury AKI is the third leading cause of death in trauma patients AKI occurs in up to 50 of patients with hemorrhagic shock and is linked to increased morbidity extended hospital stays progression to chronic kidney disease and higher short- and long-term mortality rates Even patients with mild AKI as classified by the RIFLE criteria Risk Injury Failure Loss of kidney function and End-stage kidney disease face a 25 times higher risk of mortality Battlefield conditions often delay access to definitive medical care for injured soldiers highlighting the urgent need for effective shock treatments to minimize organ damage such as AKI
The investigators propose a single-center randomized controlled trial to determine whether early initiation of proton pump inhibitor PPI pantoprazole will decrease acute kidney injury AKI for trauma patients presenting with hemorrhagic shock compared to routine timing of initiation of PPI
Our study will include adults over 18 years old who meet the criteria for hemorrhagic shock as these patients are more susceptible to hypoxic kidney damage due to bleeding and hypovolemia This will allow us to assess whether early PPI initiation can better protect the kidneys during the early stages of hypoxic damage
To evaluate this the investigators will measure urinary kidney injury biomarkers in trauma patients to compare early pantoprazole initiation study group with the usual timing of PPI initiation control group n100 primary endpoint Additionally the investigators will assess whether early pantoprazole initiation decreases the incidence severity and number of AKI-free days within the first week post-hemorrhagic shock as well as major adverse kidney events MAKE a composite of death dialysis renal hospitalization or sustained kidney dysfunction 30 days after the initial injury
The investigators propose a single-center randomized controlled trial to determine whether early initiation of proton pump inhibitor PPI pantoprazole will decrease acute kidney injury AKI for trauma patients presenting with hemorrhagic shock compared to routine timing of initiation of PPI
Our study will include adults over 18 years old who meet the criteria for hemorrhagic shock as these patients are more susceptible to hypoxic kidney damage due to bleeding and hypovolemia This will allow us to assess whether early PPI initiation can better protect the kidneys during the early stages of hypoxic damage
To evaluate this the investigators will measure urinary kidney injury biomarkers in trauma patients to compare early pantoprazole initiation study group with the usual timing of PPI initiation control group n100 primary endpoint Additionally the investigators will assess whether early pantoprazole initiation decreases the incidence severity and number of AKI-free days within the first week post-hemorrhagic shock as well as major adverse kidney events MAKE a composite of death dialysis renal hospitalization or sustained kidney dysfunction 30 days after the initial injury
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None