MAGIK for Femoral/Tibial Shaft Fractures

Phase 2

Withdrawn

• Conditions: Femoral Shaft Fracture; Tibial Shaft Fracture
• Interventions: Drug: GIK solution; Drug: Isotonic Normal Saline Solution

• Registration Number: NCT05627479
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-25
• Study Start: 2024-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GIK Therapy	GIK solution	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
Placebo Control	Isotonic Normal Saline Solution	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.

Primary Outcome Measures

Name	Time	Method
Peak Creatine Kinase (CK) Concentration During Hospital Stay	Up to Day 7 Post-Operation	Measured via standard of care lab assessment.

Secondary Outcome Measures

Name	Time	Method
Quadriceps Muscle Strength in the Injured Leg	Up to Week 52	Measured via handheld dynamometer.
Number of Participants who Experience Acute Kidney Injury (AKI)	Up to Week 52 Post-Operation
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.
Hamstrings Muscle Strength in the Uninjured Leg	Up to Week 52	Measured via handheld dynamometer.
Hamstrings Muscle Strength in the Injured Leg	Up to Week 52	Measured via handheld dynamometer.
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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States