Femoral Shaft FracturePhase 2MAGIKNCT05627479
MAGIK for Femoral/Tibial Shaft Fractures
A Phase 2 study testing GIK solution and Isotonic Normal Saline Solution in people with Femoral Shaft Fracture and Tibial Shaft Fracture, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Shaft Fracture, Tibial Shaft Fracture
- What is being tested?
- GIK solution and Isotonic Normal Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Jan 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Femoral shaft fracture or tibial shaft fracture
- Survival > 72 hours after definitive femur fracture fixation
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- GIK solution, Isotonic Normal Saline Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIK solutionDrug
Therapy cocktail of Glucose, Insulin and Potassium. The medications will be prepared as per standard protocol. Administered intravenously.
Isotonic Normal Saline SolutionDrug
Placebo injection - administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Isotonic Normal Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Creatine Kinase (CK) Concentration During Hospital Stay
Measured via standard of care lab assessment.
Measured: Up to Day 7 Post-Operation
Secondary outcomes (15)
Number of Participants who Experience Acute Kidney Injury (AKI)
Measured: Up to Week 52 Post-Operation
Number of Participants with Stage 1 AKI
Measured: Up to Week 52 Post-Operation
Number of Participants with Stage 2 AKI
Measured: Up to Week 52 Post-Operation
Number of Participants with Stage 3 AKI
Measured: Up to Week 52 Post-Operation
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.
Measured: Up to Week 52 Post-Operation
Quadriceps Muscle Strength in the Uninjured Leg
Measured via handheld dynamometer.
Measured: Up to Week 52
Quadriceps Muscle Strength in the Injured Leg
Measured via handheld dynamometer.
Measured: Up to Week 52
Hamstrings Muscle Strength in the Uninjured Leg
Measured via handheld dynamometer.
Measured: Up to Week 52
Hamstrings Muscle Strength in the Injured Leg
Measured via handheld dynamometer.
Measured: Up to Week 52
Uninjured Femur Muscle Volume at Week 4 Post-Op
Muscle volume calculated via MRI.
Measured: Week 4 Post-Operation
Injured Femur Muscle Volume at Week 4 Post-Op
Muscle volume calculated via MRI.
Measured: Week 4 Post-Operation
Uninjured Femur Muscle Volume at Week 24 Post-Op
Muscle volume calculated via MRI.
Measured: Week 24 Post-Operation
Injured Femur Muscle Volume at Week 24 Post-Op
Muscle volume calculated via MRI.
Measured: Week 24 Post-Operation
Uninjured Femur Muscle Volume at Week 52 Post-Op
Muscle volume calculated via MRI.
Measured: Week 52 Post-Operation
Injured Femur Muscle Volume at Week 52 Post-Op
Muscle volume calculated via MRI.
Measured: Week 52 Post-Operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Why it stopped: Withdrawn due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Shaft FractureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjit Konda, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627479
- Sponsor's protocol ID
- 22-01118
- Acronym
- MAGIK
- Status last verified
- Mar 2025
- First submitted
- 17 Nov 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[matthew.kingery@nyulangone.org\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05627479
- Acronym / sponsor ID
- MAGIK / 22-01118
- Conditions
- Femoral Shaft Fracture, Tibial Shaft Fracture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIK Therapy | Experimental | Drug: GIK solutionIn 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 | Placebo comparator | Drug: Isotonic Normal Saline SolutionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Femoral shaft fracture or tibial shaft fracture
- Survival > 72 hours after definitive femur fracture fixation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIK solutionTherapy cocktail of Glucose, Insulin and Potassium. The medications will be prepared as per standard protocol. Administered intravenously. | Drug | GIK Therapy |
| Isotonic Normal Saline SolutionPlacebo injection - administered intravenously. | Drug | Placebo Control |
Primary outcome
Peak Creatine Kinase (CK) Concentration During Hospital Stay
Time frame: Up to Day 7 Post-Operation
Measured via standard of care lab assessment.
15 secondary outcomes
Number of Participants who Experience Acute Kidney Injury (AKI)
Time frame: Up to Week 52 Post-Operation
Number of Participants with Stage 1 AKI
Time frame: Up to Week 52 Post-Operation
Number of Participants with Stage 2 AKI
Time frame: Up to Week 52 Post-Operation
Number of Participants with Stage 3 AKI
Time frame: Up to Week 52 Post-Operation
Patient Reported Outcome Measurement Information System (PROMIS) Physical Function
Time frame: Up to Week 52 Post-Operation
Quadriceps Muscle Strength in the Uninjured Leg
Time frame: Up to Week 52
Quadriceps Muscle Strength in the Injured Leg
Time frame: Up to Week 52
Hamstrings Muscle Strength in the Uninjured Leg
Time frame: Up to Week 52
Hamstrings Muscle Strength in the Injured Leg
Time frame: Up to Week 52
Uninjured Femur Muscle Volume at Week 4 Post-Op
Time frame: Week 4 Post-Operation
Injured Femur Muscle Volume at Week 4 Post-Op
Time frame: Week 4 Post-Operation
Uninjured Femur Muscle Volume at Week 24 Post-Op
Time frame: Week 24 Post-Operation
Injured Femur Muscle Volume at Week 24 Post-Op
Time frame: Week 24 Post-Operation
Uninjured Femur Muscle Volume at Week 52 Post-Op
Time frame: Week 52 Post-Operation
Injured Femur Muscle Volume at Week 52 Post-Op
Time frame: Week 52 Post-Operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [matthew.kingery@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjit Konda, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GIK solution and Isotonic Normal Saline Solution in people with Femoral Shaft Fracture and Tibial Shaft Fracture, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Creatine Kinase (CK) Concentration During Hospital Stay (time frame: Up to Day 7 Post-Operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.