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MAGIK for Femoral/Tibial Shaft Fractures

NCT05627479 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-03-06

No results posted yet for this study

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

Interventions

DRUG

GIK solution

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

DRUG

Isotonic Normal Saline Solution

Placebo injection - administered intravenously.

Sponsors & Collaborators

Principal Investigators

  • Sanjit Konda, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-01-01
Completion
2027-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05627479 on ClinicalTrials.gov