Muscle Trauma, ATP Depletion, and Glucose-Insulin-Potassium Therapy (The MAGIK Trial): A Randomized, Controlled Feasibility Study of GIK Therapy to Decrease Skeletal Muscle Injury in Trauma Patients With Femoral Shaft (OTA 32A-C) and Tibial Shaft (OTA 42A-C) Fractures
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Peak Creatine Kinase (CK) Concentration During Hospital Stay
研究概览
简要总结
The purpose of this phase 2 randomized control trial will be to evaluate the effect of glucose-insulin-potassium (GIK) therapy in the setting of lower extremity trauma to reduce short- and long-term muscle damage, acute rhabdomyolysis, and acute kidney injury. The study will consist of 40 patients with femur or tibial shaft fractures randomized to the GIK arm (using a well-described systemic GIK protocol; n = 20) or the control arm (using isotonic saline; n = 20). The use of systemic GIK is expected to decrease the overall amount of lower extremity muscle cell death and result in improved muscle function in the postoperative period. Additionally, the investigators hypothesize that GIK will lead to less severe rhabdomyolysis and a concomitant decrease in the incidence of AKI that results from the byproducts of muscle cell death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Femoral shaft fracture or tibial shaft fracture
- •Survival > 72 hours after definitive femur fracture fixation
排除标准
- •Pregnant women as the safety of GIK therapy in pregnant women has not been studied.
- •Age below 18 years
- •Survival < 72 hours after definitive femur fixation.
- •Pathologic fracture
- •Low energy bisphosphonate related atypical fracture
- •Patients with a contraindication to any of the medications on the study list
- •Patients with prior extremity weakness resulting from stroke or other neurological condition
- •Patients with absolute contraindications to undergoing MRI (implanted defibrillator or pacemaker, implanted deep brain stimulator, bullets or gunshot pellets near great vessels or vital organs, cerebral aneurysm clips, cochlear implants, magnetic dental implants).
研究组 & 干预措施
GIK Therapy
In patients randomized to the GIK Therapy Arm, a stepwise GIK infusion process will be performed. Baseline lab values that are markers of skeletal muscle injury (CPK), acute kidney injury (creatinine), and general tissue perfusion (lactate) will be obtained within the first 30 min of arrival to the ED. Subsequently, serial CPK, creatinine, myoglobin and lactate values will be obtained at regularly scheduled intervals until a minimum of 72 hours after definitive fixation or until rhabdomyolysis is resolved and/or kidney function has normalized
干预措施: GIK solution (Drug)
Placebo Control
Patients randomized to the control cohort will receive a normal saline infusion instead of GIK. Standard institutional ICU protocol will be used to monitor potassium and glucose levels per current standard-of-care practices and abnormal lab values will be treated accordingly per standard institutional protocols.
干预措施: Isotonic Normal Saline Solution (Drug)
结局指标
主要结局
Peak Creatine Kinase (CK) Concentration During Hospital Stay
时间窗: Up to Day 7 Post-Operation
Measured via standard of care lab assessment.
次要结局
- Number of Participants who Experience Acute Kidney Injury (AKI)(Up to Week 52 Post-Operation)
- Number of Participants with Stage 1 AKI(Up to Week 52 Post-Operation)
- Number of Participants with Stage 2 AKI(Up to Week 52 Post-Operation)
- Number of Participants with Stage 3 AKI(Up to Week 52 Post-Operation)
- Patient Reported Outcome Measurement Information System (PROMIS) Physical Function(Up to Week 52 Post-Operation)
- Quadriceps Muscle Strength in the Uninjured Leg(Up to Week 52)
- Quadriceps Muscle Strength in the Injured Leg(Up to Week 52)
- Hamstrings Muscle Strength in the Uninjured Leg(Up to Week 52)
- Hamstrings Muscle Strength in the Injured Leg(Up to Week 52)
- Uninjured Femur Muscle Volume at Week 4 Post-Op(Week 4 Post-Operation)
- Injured Femur Muscle Volume at Week 4 Post-Op(Week 4 Post-Operation)
- Uninjured Femur Muscle Volume at Week 24 Post-Op(Week 24 Post-Operation)
- Injured Femur Muscle Volume at Week 24 Post-Op(Week 24 Post-Operation)
- Uninjured Femur Muscle Volume at Week 52 Post-Op(Week 52 Post-Operation)
- Injured Femur Muscle Volume at Week 52 Post-Op(Week 52 Post-Operation)