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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Urinary Kidney Biomarker Levels
研究概览
简要总结
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 early(study) or routine (control) administration of pantoprazole for 2 days after the initial injury insult.
详细描述
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 2.5 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) (n=100, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Partial blinded, only the laboratory testing technician/outcome assessor will be blinded to the study arms.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Early Initiation
Within 2 hours of emergency department (ED) admission after inclusion criteria is met, administer 1st dose of Protonix (pantoprazole) 40 mg, then followed by 40 mg q12hrs for 2 additional days
干预措施: Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days (Drug)
Usual Care
Administer 1st dose of 40 mg Protonix (pantoprazole) at the usual timing (current practice: in the intensive care unit), then followed by 40 mg daily for 2 additional days.
干预措施: Protonix (pantoprazole) 40 mg q 24 hrs for 2 days (Drug)
结局指标
主要结局
Urinary Kidney Biomarker Levels
时间窗: From enrollment until 48 hours after injury
The investigators will measure the urinary kidney biomarker KIM-1 (kidney injury molecule-1) levels at the different time points of urine sample collection (baseline, 8 hrs, 24 hrs and 48 hrs)
次要结局
- Acute Kidney Injury Staging(From enrollment until 5 days of initial injury)
- Major Adverse Kidney Events(From enrollment until 30 days of initial injury)
研究者
yafen liang
M.D., Professor, Chief of Division of Cardiovascular Anesthesiology, Vice Chair of Clinical Research
The University of Texas Health Science Center, Houston