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Not Yet Recruiting NCT05627479

MAGIK for Femoral/Tibial Shaft Fractures

Conditions: Femoral Shaft Fracture, Tibial Shaft Fracture

Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 50
Sponsor: NYU Langone Health

Location: United States

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:Femoral shaft fracture or tibial shaft fractureSurvival > 72 hours after definitive femur fracture fixationExclusion Criteria:Pregnant women as the safety of GIK therapy in pregnant women has not been studied.Age below 18 yearsSurvival < 72 hours after definitive femur fixation.Pathologic fractureLow energy bisphosphonate related atypical fracturePatients with a contraindication to any of the medications on the study listPatients with prior extremity weakness resulting from stroke or other neurological conditionPatients 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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05627479). StuddyBuddy aggregates publicly available trial information.