MAGIK for Femoral/Tibial Shaft Fractures

Femoral Shaft Fracture Clinical Trial

— MAGIK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05627479
• Other study ID #: 22-01118
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Matthew Kingery, MD
• Phone: 212-598-6000
• Email: matthew.kingery[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Femoral Shaft Fracture
• Fractures, Bone
• Tibial Shaft Fracture

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Creatine Kinase (CK) Concentration During Hospital Stay	Measured via standard of care lab assessment.	Up to Day 7 Post-Operation
Secondary	Number of Participants who Experience Acute Kidney Injury (AKI)		Up to Week 52 Post-Operation
Secondary	Number of Participants with Stage 1 AKI		Up to Week 52 Post-Operation
Secondary	Number of Participants with Stage 2 AKI		Up to Week 52 Post-Operation
Secondary	Number of Participants with Stage 3 AKI		Up to Week 52 Post-Operation
Secondary	Patient Reported Outcome Measurement Information System (PROMIS) Physical Function	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.	Up to Week 52 Post-Operation
Secondary	Quadriceps Muscle Strength in the Uninjured Leg	Measured via handheld dynamometer.	Up to Week 52
Secondary	Quadriceps Muscle Strength in the Injured Leg	Measured via handheld dynamometer.	Up to Week 52
Secondary	Hamstrings Muscle Strength in the Uninjured Leg	Measured via handheld dynamometer.	Up to Week 52
Secondary	Hamstrings Muscle Strength in the Injured Leg	Measured via handheld dynamometer.	Up to Week 52
Secondary	Uninjured Femur Muscle Volume at Week 4 Post-Op	Muscle volume calculated via MRI.	Week 4 Post-Operation
Secondary	Injured Femur Muscle Volume at Week 4 Post-Op	Muscle volume calculated via MRI.	Week 4 Post-Operation
Secondary	Uninjured Femur Muscle Volume at Week 24 Post-Op	Muscle volume calculated via MRI.	Week 24 Post-Operation
Secondary	Injured Femur Muscle Volume at Week 24 Post-Op	Muscle volume calculated via MRI.	Week 24 Post-Operation
Secondary	Uninjured Femur Muscle Volume at Week 52 Post-Op	Muscle volume calculated via MRI.	Week 52 Post-Operation
Secondary	Injured Femur Muscle Volume at Week 52 Post-Op	Muscle volume calculated via MRI.	Week 52 Post-Operation