GIK Therapy for Broken Leg Bones

(MAGIK Trial)

Overseen By Matthew Kingery, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Age below 18, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Up to 1 week

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sanjit Konda, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults with femoral or tibial shaft fractures who have survived more than 72 hours after definitive fracture fixation. It's not for those under 18, pregnant women, patients with certain types of low energy fractures, prior limb weakness due to neurological conditions, pathologic fractures, or anyone with contraindications to MRI or the study medications.

Inclusion Criteria

I have a broken thigh bone or shin bone.

Survival > 72 hours after definitive femur fracture fixation

Exclusion Criteria

I survived less than 72 hours after my femur surgery.

Pregnant women as the safety of GIK therapy in pregnant women has not been studied

I have had a fracture due to my disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either GIK therapy or placebo control with monitoring of lab values for muscle injury and kidney function

Up to 1 week

Daily monitoring during hospital stay

Follow-up

Participants are monitored for muscle strength and volume, and physical function up to 52 weeks post-operation

52 weeks

Regular follow-up visits for assessments

Treatment Details

Interventions

• GIK solution
• Isotonic Normal Saline Solution

Trial Overview The MAGIK trial is testing whether a glucose-insulin-potassium (GIK) solution can reduce muscle damage and kidney injury after lower extremity trauma compared to normal saline. The study will randomly assign 40 patients into two groups: one receiving GIK therapy and the other receiving saline as a control.

Participant Groups

Group I: GIK Therapy Experimental Treatment 1 Intervention

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

Group II: Placebo Control Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+