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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Therapy cocktail of Glucose, Insulin and Potassium. The medications will be prepared as per standard protocol. Administered intravenously.
Placebo injection - administered intravenously.
NYU Langone Health
New York, New York, United States
Peak Creatine Kinase (CK) Concentration During Hospital Stay
Measured via standard of care lab assessment.
Time frame: Up to Day 7 Post-Operation
Number of Participants who Experience Acute Kidney Injury (AKI)
Time frame: Up to Week 52 Post-Operation
Number of Participants with Stage 1 AKI
Time frame: Up to Week 52 Post-Operation
Number of Participants with Stage 2 AKI
Time frame: Up to Week 52 Post-Operation
Number of Participants with Stage 3 AKI
Time frame: Up to Week 52 Post-Operation
Patient Reported Outcome Measurement Information System (PROMIS) Physical Function
Measure of self-reported capability rather than actual performance of physical activities. The raw score is the sum of responses and is calculated into a T-score with a mean of 50 and a standard deviation of 10; higher scores indicate greater physical function.
Time frame: Up to Week 52 Post-Operation
Quadriceps Muscle Strength in the Uninjured Leg
Measured via handheld dynamometer.
Time frame: Up to Week 52
Quadriceps Muscle Strength in the Injured Leg
Measured via handheld dynamometer.
Time frame: Up to Week 52
Hamstrings Muscle Strength in the Uninjured Leg
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Measured via handheld dynamometer.
Time frame: Up to Week 52
Hamstrings Muscle Strength in the Injured Leg
Measured via handheld dynamometer.
Time frame: Up to Week 52
Uninjured Femur Muscle Volume at Week 4 Post-Op
Muscle volume calculated via MRI.
Time frame: Week 4 Post-Operation
Injured Femur Muscle Volume at Week 4 Post-Op
Muscle volume calculated via MRI.
Time frame: Week 4 Post-Operation
Uninjured Femur Muscle Volume at Week 24 Post-Op
Muscle volume calculated via MRI.
Time frame: Week 24 Post-Operation
Injured Femur Muscle Volume at Week 24 Post-Op
Muscle volume calculated via MRI.
Time frame: Week 24 Post-Operation
Uninjured Femur Muscle Volume at Week 52 Post-Op
Muscle volume calculated via MRI.
Time frame: Week 52 Post-Operation
Injured Femur Muscle Volume at Week 52 Post-Op
Muscle volume calculated via MRI.
Time frame: Week 52 Post-Operation