Femoral Shaft Fracture, Tibial Shaft Fracture
Conditions
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.
Interventions
DRUGGIK solution
Therapy cocktail of Glucose, Insulin and Potassium. The medications will be prepared as per standard protocol. Administered intravenously.
DRUGIsotonic Normal Saline Solution
Placebo injection - administered intravenously.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Creatine Kinase (CK) Concentration During Hospital Stay | Up to Day 7 Post-Operation | Measured via standard of care lab assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Quadriceps Muscle Strength in the Uninjured Leg | Up to Week 52 | Measured via handheld dynamometer. |
| Quadriceps Muscle Strength in the Injured Leg | Up to Week 52 | Measured via handheld dynamometer. |
| Hamstrings Muscle Strength in the Uninjured Leg | Up to Week 52 | Measured via handheld dynamometer. |
| Number of Participants who Experience Acute Kidney Injury (AKI) | Up to Week 52 Post-Operation | — |
| Uninjured Femur Muscle Volume at Week 4 Post-Op | Week 4 Post-Operation | Muscle volume calculated via MRI. |
| Injured Femur Muscle Volume at Week 4 Post-Op | Week 4 Post-Operation | Muscle volume calculated via MRI. |
| Uninjured Femur Muscle Volume at Week 24 Post-Op | Week 24 Post-Operation | Muscle volume calculated via MRI. |
| Injured Femur Muscle Volume at Week 24 Post-Op | Week 24 Post-Operation | Muscle volume calculated via MRI. |
| Uninjured Femur Muscle Volume at Week 52 Post-Op | Week 52 Post-Operation | Muscle volume calculated via MRI. |
| Injured Femur Muscle Volume at Week 52 Post-Op | Week 52 Post-Operation | Muscle volume calculated via MRI. |
| Hamstrings Muscle Strength in the Injured Leg | Up to Week 52 | Measured via handheld dynamometer. |
Countries
United States
Outcome results
None listed