Changes in Resting Metabolic Rate Following Orthopedic Surgery

Resting Metabolic Rate Clinical Trial

Official title:

Changes in Resting Metabolic Rate Following Orthopedic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06107959
• Other study ID #: STUDY00150689
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: University of Kansas Medical Center
• Contact: Sharon Bradshaw
• Phone: 913-945-6289
• Email: sbradshaw2[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project is intended to determine the magnitude and duration of RMR changes in patients receiving orthopedic surgery. The result will help to guide postoperative nutrition recommendations in patients receiving orthopedic surgery.

Description:

Surgery produces a catabolic response in the body that shifts metabolism from glucose to fat and protein. Despite no studies examining ACLR, studies of other orthopedic surgeries demonstrate increased postoperative energy expenditure, as well as a shift to beta-oxidation. Additionally, in most patients, these changes reverted to baseline within six weeks, although a subset of patients did not return to baseline until beyond 12 weeks. This project will improve our understanding of magnitude and duration of RMR changes following orthopedic surgery, and the subsequent perioperative dietary suggestions that should be made to improve patient outcomes. Currently, postoperative dietary suggestions are not surgery nor patient specific. Determining how orthopedic surgery effects RMR will help to personalize perioperative treatment, rehabilitation, and recovery. Better understanding the change in RMR following orthopedic surgery and implementing more accurate dietary modifications will help to ensure positive outcomes and control of infection following orthopedic surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Any individual over 15 undergoing an orthopedic surgery.

Exclusion Criteria:

• Pregnant female
• < 15 years old

Related Conditions & MeSH terms

• Metabolic Diseases
• Post Operative Nutrition
• Resting Metabolic Rate

Intervention

Other:
• Pre-surgical nutrition, hydration, RMR, and body composition assessments
Urine sample, InBody device platform, Metabolic cart with hood to collect RMR.
• Post-surgical nutrition, hydration, RMR and body composition assessments
Same as pre-surgical tests at 1 week, 3 weeks, 6 weeks, and 12 weeks follow up time points.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

References & Publications (6)

Braga M, Baccari P, Scaccabarozzi S, Fiacco E, Radaelli G, Gallus G, DiPalo S, DiCarlo V, Cristallo M. Prognostic role of preoperative nutritional and immunological assessment in the surgical patient. JPEN J Parenter Enteral Nutr. 1988 Mar-Apr;12(2):138-42. doi: 10.1177/0148607188012002138. — View Citation

Hu SS, Fontaine F, Kelly B, Bradford DS. Nutritional depletion in staged spinal reconstructive surgery. The effect of total parenteral nutrition. Spine (Phila Pa 1976). 1998 Jun 15;23(12):1401-5. doi: 10.1097/00007632-199806150-00019. — View Citation

Lenke LG, Bridwell KH, Blanke K, Baldus C. Prospective analysis of nutritional status normalization after spinal reconstructive surgery. Spine (Phila Pa 1976). 1995 Jun 15;20(12):1359-67. — View Citation

Ljungqvist O, Soop M, Hedstrom M. Why metabolism matters in elective orthopedic surgery: a review. Acta Orthop. 2007 Oct;78(5):610-5. doi: 10.1080/17453670710014293. No abstract available. — View Citation

Malone DL, Genuit T, Tracy JK, Gannon C, Napolitano LM. Surgical site infections: reanalysis of risk factors. J Surg Res. 2002 Mar;103(1):89-95. doi: 10.1006/jsre.2001.6343. — View Citation

McMulkin ML, Ferguson RL. Resting energy expenditure and respiratory quotient in adolescents following spinal fusion surgery. Spine (Phila Pa 1976). 2004 Aug 15;29(16):1831-5. doi: 10.1097/01.brs.0000134564.24874.10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the magnitude of the change in RMR of patients receiving orthopedic surgery.	RMR = (9.99 X actual weight*)+ (6.25 X height*) - (4.92 X age) - 161*use weight in kilograms (kilogram), height in centimeters (cm).	12 weeks
Primary	To observe the amount of time it takes the RMR to return to baseline.	calculation in number of weeks	12 weeks