## Protocol Section
### Identification Module
**NCT ID:** NCT05627479

**Acronym:** MAGIK

**Brief Title:** MAGIK for Femoral/Tibial Shaft Fractures

**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

#### Organization Study ID Info
**ID:** 22-01118
#### Organization
**Class:** OTHER
**Full Name:** NYU Langone Health
### Status Module
#### Completion Date
**Date:** 2027-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-28

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-12-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2022-11-25
**Type:** ACTUAL
**Study First Submit Date:** 2022-11-17
**Study First Submit QC Date:** 2022-11-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** NYU Langone Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Femoral Shaft Fracture

- Tibial Shaft Fracture

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Drug: GIK solution

**Label:** GIK Therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: Isotonic Normal Saline Solution

**Label:** Placebo Control

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- GIK Therapy

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

**Name:** GIK solution

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo Control

**Description:** Placebo injection - administered intravenously.

**Name:** Isotonic Normal Saline Solution

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Measured via standard of care lab assessment.

**Measure:** Peak Creatine Kinase (CK) Concentration During Hospital Stay

**Time Frame:** Up to Day 7 Post-Operation

#### Secondary Outcomes

**Measure:** Number of Participants who Experience Acute Kidney Injury (AKI)

**Time Frame:** Up to Week 52 Post-Operation

**Measure:** Number of Participants with Stage 1 AKI

**Time Frame:** Up to Week 52 Post-Operation

**Measure:** Number of Participants with Stage 2 AKI

**Time Frame:** Up to Week 52 Post-Operation

**Measure:** Number of Participants with Stage 3 AKI

**Time Frame:** Up to Week 52 Post-Operation

**Description:** 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.

**Measure:** Patient Reported Outcome Measurement Information System (PROMIS) Physical Function

**Time Frame:** Up to Week 52 Post-Operation

**Description:** Measured via handheld dynamometer.

**Measure:** Quadriceps Muscle Strength in the Uninjured Leg

**Time Frame:** Up to Week 52

**Description:** Measured via handheld dynamometer.

**Measure:** Quadriceps Muscle Strength in the Injured Leg

**Time Frame:** Up to Week 52

**Description:** Measured via handheld dynamometer.

**Measure:** Hamstrings Muscle Strength in the Uninjured Leg

**Time Frame:** Up to Week 52

**Description:** Measured via handheld dynamometer.

**Measure:** Hamstrings Muscle Strength in the Injured Leg

**Time Frame:** Up to Week 52

**Description:** Muscle volume calculated via MRI.

**Measure:** Uninjured Femur Muscle Volume at Week 4 Post-Op

**Time Frame:** Week 4 Post-Operation

**Description:** Muscle volume calculated via MRI.

**Measure:** Injured Femur Muscle Volume at Week 4 Post-Op

**Time Frame:** Week 4 Post-Operation

**Description:** Muscle volume calculated via MRI.

**Measure:** Uninjured Femur Muscle Volume at Week 24 Post-Op

**Time Frame:** Week 24 Post-Operation

**Description:** Muscle volume calculated via MRI.

**Measure:** Injured Femur Muscle Volume at Week 24 Post-Op

**Time Frame:** Week 24 Post-Operation

**Description:** Muscle volume calculated via MRI.

**Measure:** Uninjured Femur Muscle Volume at Week 52 Post-Op

**Time Frame:** Week 52 Post-Operation

**Description:** Muscle volume calculated via MRI.

**Measure:** Injured Femur Muscle Volume at Week 52 Post-Op

**Time Frame:** Week 52 Post-Operation

### Eligibility Module

**Eligibility Criteria:** 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).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** matthew.kingery@nyulangone.org

**Name:** Matthew Kingery, MD

**Phone:** 212-598-6000

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** matthew.kingery@nyulangone.org

- **Name:** Matthew Kingery, MD

- **Phone:** 212-598-6000

- **Role:** CONTACT

**Country:** United States

**Facility:** NYU Langone Health

**State:** New York

**Zip:** 10016

#### Overall Officials

**Official 1:**

**Affiliation:** NYU Langone Health

**Name:** Sanjit Konda, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**Description:** 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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**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.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M26370

- Name: Fractures, Bone

- Relevance: HIGH

- As Found: Fracture

### Condition Browse Module - Meshes

- ID: D000050723

- Term: Fractures, Bone

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: HIGH

- As Found: Procedure

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000019999

- Term: Pharmaceutical Solutions

### Misc Info Module

- Version Holder: 2024-05-24
