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GIK Therapy for Broken Leg Bones (MAGIK Trial)
Phase 2
Waitlist Available
Led By Sanjit Konda, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52
Awards & highlights
MAGIK Trial Summary
This trial will test a glucose-insulin-potassium therapy to reduce muscle damage, rhabdomyolysis and kidney injury in patients with leg fractures. 40 patients will be randomized to use the therapy or a control.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects from GIK therapy may include changes in blood sugar levels, potential electrolyte imbalances like high potassium or low sodium levels which could affect heart rhythm and fluid balance.
MAGIK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Peak Creatine Kinase (CK) Concentration During Hospital Stay
Secondary outcome measures
Hamstrings Muscle Strength in the Injured Leg
Hamstrings Muscle Strength in the Uninjured Leg
Injured Femur Muscle Volume at Week 24 Post-Op
+12 moreSide effects data
From 2014 Phase 4 trial • 40 Patients • NCT0160269240%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine
MAGIK Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GIK TherapyExperimental Treatment1 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 ControlPlacebo Group1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GIK solution
2011
Completed Phase 4
~70
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,711 Total Patients Enrolled
Sanjit Konda, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I survived less than 72 hours after my femur surgery.I have had a fracture due to my disease.I have a broken thigh bone or shin bone.I am under 18 years old.I have a fracture related to low energy and bisphosphonate use.I have had weakness in my arms or legs due to a stroke or other neurological condition.I am allergic or cannot take certain medications required for the study.
Research Study Groups:
This trial has the following groups:- Group 1: GIK Therapy
- Group 2: Placebo Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots in this clinical trial?
"According to information hosted on clinicaltrials.gov, this particular medical trial is no longer actively seeking participants; it was initially posted on January 1st 2023 and its most recent update occurred November 17th 2022. Despite the fact that there are not any current openings for this study, 347 other trials have open slots right now."
Answered by AI
Has GIK Therapy been given a stamp of approval by the Food and Drug Administration?
"While the efficacy of GIK Therapy is yet to be determined, there is some clinical data demonstrating its safety, scoring it a 2 on our internal rating system."
Answered by AI
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