Clinical trial NCT05627479: MAGIK for Femoral/Tibial Shaft Fractures
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Femoral Shaft Fracture
Tibial Shaft Fracture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Femoral shaft fracture or tibial shaft fracture
2. Survival \> 72 hours after definitive femur fracture fixation

Exclusion Criteria:

1. Pregnant women as the safety of GIK therapy in pregnant women has not been studied.
2. Age below 18 years
3. Survival \< 72 hours after definitive femur fixation.
4. Pathologic fracture
5. Low energy bisphosphonate related atypical fracture
6. Patients with a contraindication to any of the medications on the study list
7. Patients with prior extremity weakness resulting from stroke or other neurological condition
8. 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).

Primary outcomes:
measure: Peak Creatine Kinase (CK) Concentration During Hospital Stay
timeFrame: Up to Day 7 Post-Operation
Secondary outcomes:
measure: Number of Participants who Experience Acute Kidney Injury (AKI)
timeFrame: Up to Week 52 Post-Operation
measure: Number of Participants with Stage 1 AKI
timeFrame: Up to Week 52 Post-Operation
measure: Number of Participants with Stage 2 AKI
timeFrame: Up to Week 52 Post-Operation
measure: Number of Participants with Stage 3 AKI
timeFrame: Up to Week 52 Post-Operation
measure: Patient Reported Outcome Measurement Information System (PROMIS) Physical Function
timeFrame: Up to Week 52 Post-Operation
measure: Quadriceps Muscle Strength in the Uninjured Leg
timeFrame: Up to Week 52
measure: Quadriceps Muscle Strength in the Injured Leg
timeFrame: Up to Week 52
measure: Hamstrings Muscle Strength in the Uninjured Leg
timeFrame: Up to Week 52
measure: Hamstrings Muscle Strength in the Injured Leg
timeFrame: Up to Week 52
measure: Uninjured Femur Muscle Volume at Week 4 Post-Op
timeFrame: Week 4 Post-Operation
measure: Injured Femur Muscle Volume at Week 4 Post-Op
timeFrame: Week 4 Post-Operation
measure: Uninjured Femur Muscle Volume at Week 24 Post-Op
timeFrame: Week 24 Post-Operation
measure: Injured Femur Muscle Volume at Week 24 Post-Op
timeFrame: Week 24 Post-Operation
measure: Uninjured Femur Muscle Volume at Week 52 Post-Op
timeFrame: Week 52 Post-Operation
measure: Injured Femur Muscle Volume at Week 52 Post-Op
timeFrame: Week 52 Post-Operation
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sanjit Konda, MD
role: PRINCIPAL_INVESTIGATOR
References: