Nutritional Perihabilitation in Older Veterans Undergoing Surgery

Malnutrition Clinical Trial

Official title:

Nutritional (High Protein) Perihabilitation in Older Veterans Undergoing Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073811
• Other study ID #: E2348-W
• Secondary ID: IK2RX002348
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: March 31, 2022

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study will be conducted in two parts. The first part will consist of selecting appropriate screening and assessment tools for Veterans undergoing elective surgery and identifying the number of Veterans who are malnourished and at risk of malnutrition. The second portion of the study will be to determine if a protein-enhanced diet before and after surgery will improve function and postoperative outcomes and compare the results to an education control group.

Description:

In year 1 of the two-part research study, an observational, prospective study of 75 Veterans preparing for elective surgery will be conducted. The purpose of this study will be to select appropriate nutrition screening and assessment tools and to employ them to characterize malnutrition prevalence and severity and establish cut-off values associated with malnutrition in this population. In years 2-5 of the research two-part research study, a pilot randomized controlled trial will be conducted. The purpose of this study will be evaluate the feasibility, fidelity, and acceptability of a perioperative protein-enhanced intervention compared to an educational control. Veterans who are malnourished or at risk of being malnourished will be randomly assigned on a 1:1 ratio to either an education (nutritional counseling) control or high-protein perihabilitation arm. Participants in the high-protein perihabilitation arm will be provided with 30 grams of high quality protein supplements three times per day. The study will take place two weeks prior to an elective abdominal or GI surgery and will continue 4 weeks post surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Elective abdominal surgery
• upper GI
• colorectal
• hepatobiliary
• pancreatic
• intra-abdominal
• Abdominal aortic aneurysm
• Referred to the VA Perioperative Optimization of Senior Health Clinic
• Able to record dietary intake or has a proxy who can record dietary intake

Exclusion Criteria:

• Cognitive impairment
• Unwillingness to be randomized to either intervention arm, submit to study testing, or continuously participate in the intervention for six weeks
• Living in skilled nursing facility
• No access to telephone

Related Conditions & MeSH terms

• Abdominal Surgery
• Malnutrition
• Nutritional Risk

Intervention

Dietary Supplement:
• Protein enhanced nutrition intervention
Participants will be provided 30 grams of high quality protein (Ensure Max) three times a day for two weeks before surgery and four weeks after surgery.

Other:
• Education Control
provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.	Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained.	day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)
Primary	Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control	Satisfaction of overall participation in the research study (Likert Scale). I am glad I participated in this research study. 1 - Strongly Disagree and 5- Strongly Agree	30-day post-surgery follow-up (endpoint)
Primary	Physical Function	Short physical performance battery - higher scores means a better physical performance (Total score = 0-12)	Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery
Secondary	Hospital Readmission	determine from medical records	endpoint (30 days post-surgery)
Secondary	Dietary Intake	Three day food records will be collected.	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Secondary	Handgrip Strength	Hand dynamometer will be used to determine grip strength. Maximum grip strength will be determined by conducting two trials on the dominant hand, with 30 second rest between trials.	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Secondary	Nutritional Risk Screener-2002	Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Secondary	Patient Generated-Subjective Global Assessment	Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Secondary	Discharge Location	determine from medical records	endpoint (30 days post-surgery)
Secondary	Length of Stay	determine from medical records	endpoint (30 days post-surgery)
Secondary	Emergency Department Readmission	Prevalence of emergency department admissions following surgery.	endpoint (30 days post-surgery)
Secondary	Postoperative Complications	determine from medical records	endpoint (30 days post-surgery)
Secondary	Albumin, g/dL	A measure of protein in the blood. Lower level may indicate infection or inflammation.	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)