MAGIK for Femoral/Tibial Shaft Fractures

NYU Langone Health

Status and phase: Withdrawn; Phase 2

Conditions: Tibial Shaft Fracture; Femoral Shaft Fracture

Treatments: Drug: Isotonic Normal Saline Solution; Drug: GIK solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05627479

22-01118

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

GIK Therapy

Experimental group

Description:

In patients randomized to the GIK Therapy Arm, a stepwise GIK infusion process will be performed. Baseline lab values that are markers of skeletal muscle injury (CPK), acute kidney injury (creatinine), and general tissue perfusion (lactate) will be obtained within the first 30 min of arrival to the ED. Subsequently, serial CPK, creatinine, myoglobin and lactate values will be obtained at regularly scheduled intervals until a minimum of 72 hours after definitive fixation or until rhabdomyolysis is resolved and/or kidney function has normalized

Treatment:

Drug: GIK solution

Placebo Control

Placebo Comparator group

Description:

Patients randomized to the control cohort will receive a normal saline infusion instead of GIK. Standard institutional ICU protocol will be used to monitor potassium and glucose levels per current standard-of-care practices and abnormal lab values will be treated accordingly per standard institutional protocols.

Treatment:

Drug: Isotonic Normal Saline Solution