BridgeMD
Compares treatment options for Acute Kidney Injury
Official title Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients
ClinicalTrials.gov ID: NCT06531642
What this study is testing
What is Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days?
Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days is an investigational medicine, being studied as a potential treatment for acute kidney injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Adult patient (≥18 years of age)
- Patient meets hemorrhagic shock criteria:
- Hypovolemic shock from traumatic acute bleeding
- Systolic blood pressure ≤ 90 mmHg AND tachycardia (HR ≥ 108) at presentation to the ED; OR
- Systolic blood pressure ≤ 70 mmHg at presentation to the ED.
You likely can't join if
- Patients \<18 years of age
- Patients known to be actively on renal replacement therapy
- Cardiac arrest prior to ED arrival or who are deemed to have expected survival of less than 24 hours
- History of PPI sensitivity or allergy
- Patient who are already enrolled in other trials prior to ED arrival and these trials do not allow co-enrollment
- Patient who presents with ongoing GI bleeding that will require higher dose of GI prophylaxis
See the full eligibility criteria
- Adult patient (≥18 years of age)
- Patient meets hemorrhagic shock criteria:
- Hypovolemic shock from traumatic acute bleeding
- Systolic blood pressure ≤ 90 mmHg AND tachycardia (HR ≥ 108) at presentation to the ED; OR
- Systolic blood pressure ≤ 70 mmHg at presentation to the ED.
- Patients \<18 years of age
- Patients known to be actively on renal replacement therapy
- Cardiac arrest prior to ED arrival or who are deemed to have expected survival of less than 24 hours
- History of PPI sensitivity or allergy
- Patient who are already enrolled in other trials prior to ED arrival and these trials do not allow co-enrollment
- Patient who presents with ongoing GI bleeding that will require higher dose of GI prophylaxis
- Vulnerable populations such as pregnant women and prisoners
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.