NCT05627479

MAGIK for Femoral/Tibial Shaft Fractures

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoral Shaft Fracture
• Tibial Shaft Fracture

Interventions

Type	Name	Description
DRUG	GIK solution	Therapy cocktail of Glucose, Insulin and Potassium. The medications will be prepared as per standard protocol. Administered intravenously.
DRUG	Isotonic Normal Saline Solution	Placebo injection - administered intravenously.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2022-11-25
• Last updated: 2025-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study