Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Amir h Fathi, MD (ucsf)
Photo of Amir h Fathi
Amir h Fathi

Description

Summary

Malnutrition is a serious problem in patients undergoing major surgeries and has a direct association with increased morbidity, mortality, length of stay (LOS), increased readmissions and cost of care. Studies suggest several advantages of supplementation with protein or specific amino acids in malnourished patients. Dietary leucine or its metabolite β-hydroxy β-methylbutyrate (HMB) can improve skeletal muscle mass and function by increasing transcriptional level of protein synthase, while other high protein or amino acids like Glutamine or Arginine supplements only provide protein-amino acids pool for patients while body's preferred fuel during metabolic stress is endogens protein, rather than exogenous diet. In this study the investigators seek to achieve two distinct goals: 1. Determine the patients' nutritional status before and after major surgeries by baseline and subsequent nutritional assessments, according to ASPEN's criteria. In addition, the investigators were going to use indirect calorimetry to determine the Resting Energy Expenditure (REE) in different phases of pre- and postoperative periods. The investigators also propose to compare different serum protein markers and their ratios in order to correlate them with ASPEN's criteria for nutritional status quantification. In Summary, three discrete tools including ASPEN's criteria, indirect calorimetry, and serum biomarkers are going to be used in conjunction with each other to delineate the patients' nutritional status in various pre- and post-operative periods. 2. Patients undergoing major surgeries were supplemented with high protein with ß-hydroxy ß-methylbutyrate (HMB) (Ensure, Envile) or HMB only as a control, in order to improve their nutritional status and improve postoperative outcomes. The investigators looked for depict meaningful improvements in surgical outcomes by nutritional supplementation with or without HMB.

Official Title

Effects of Nutritional Preconditioning on the Nutritional Status of Patients Undergoing Major General Surgeries and Subsequent Operative Outcomes

Details

Hypotheses: We hypothesize that patients receiving high protein nutritional supplementation with HMB (Ensure Enlive) will have meaningful improvements in surgical outcomes rather than if they receive HMB only. Also, by comparing different methods of malnutrition designation, we are hypothesizing that by conduction this study, we will have a better understanding of malnutrition and its consequences in the Central Valley of California. Furthermore, we are planning to improve patient outcomes and significantly reduce the health care costs of the Valley by proper nutritional supplementation. Specific Aims: Demonstrate the important role β-hydroxy β-methyl butyrate (HMB) supplementation with or without high protein nutrition supplement in patients undergoing major surgeries and their outcomes. Develop the current ERAS protocol used in Community Regional Medical Center by determining the best oral nutrition supplement prior to surgery Emphasize the importance of using oral nutrition supplements before major surgeries to decrease the patient's recovery after surgeries.

Keywords

Major Abdominal/GI Surgery HMB: β-hydroxy β-methylbutyrate MNA: Mini Nutrition Assessment GMS: Graz Malnutrition Screening MUST: Malnutrition Universal Screening Tool MST: Malnutrition Screening Tool SGA: Subjective Global Assessment REE: Resting Energy Expenditure IC: Indirect calorimetry HMB Protein and HMB ERAS HMB only Current ERAS (High Protein)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Dr. Amir Fathi as attending surgeon
  • Adult patients (age >18) undergoing major abdominal and GI surgeries
  • Patients at risk for malnutrition based on the ASPEN and The Academy malnutrition criteria

You CAN'T join if...

  • Pediatric patients
  • Patients undergoing chemotherapy or radiation
  • Patients with known allergies to products (Ensure Enlive, HMB)
  • Patients that are unable to comply with all requirements
  • Vegan patients
  • Pregnant patients
  • Prisoners

Location

  • Community Regional Medical Center accepting new patients
    Fresno California 93721 United States

Lead Scientist at University of California Health

  • Amir h Fathi, MD (ucsf)
    Associate Professor, Dean's Office. Authored (or co-authored) 7 research publications. Research interests: Dr. Fathi’s practice includes surgical treatment of the following: primary and metastatic tumors of the Liver · Pancreas · Gallbladder · biliary tree · Stomach and foregut · surgical management of acute and chronic pancreatitis · complex abdominal wall reconstruction

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03692507
Study Type
Interventional
Last Updated