MAGIK for Femoral/Tibial Shaft Fractures

NCT05627479 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 22-01118
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Shaft Fracture; Tibial Shaft Fracture

Outcome Measures

Primary Outcomes (1)

• Peak Creatine Kinase (CK) Concentration During Hospital Stay

  Measured via standard of care lab assessment.

  Up to Day 7 Post-Operation

Secondary Outcomes (15)

• 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

Study Arms (2)

GIK Therapy

EXPERIMENTAL

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

Drug: GIK solution

Placebo Control

PLACEBO COMPARATOR

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.

Drug: Isotonic Normal Saline Solution

Interventions

GIK solution DRUG

Therapy cocktail of Glucose, Insulin and Potassium. The medications will be prepared as per standard protocol. Administered intravenously.

GIK Therapy

Isotonic Normal Saline Solution DRUG

Placebo injection - administered intravenously.

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Femoral shaft fracture or tibial shaft fracture
• Survival \> 72 hours after definitive femur fracture fixation

You may not qualify if:

• Pregnant women as the safety of GIK therapy in pregnant women has not been studied.
• Age below 18 years
• Survival \< 72 hours after definitive femur fixation.
• Pathologic fracture
• Low energy bisphosphonate related atypical fracture
• Patients with a contraindication to any of the medications on the study list
• Patients with prior extremity weakness resulting from stroke or other neurological condition
• 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).

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

glucose-insulin-potassium cardioplegic solution

Study Officials

• Sanjit Konda, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 25, 2022
• Study Start: December 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be given access to the data upon reasonable request. Requests should be directed to matthew.kingery@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)