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Clinical Trials/NCT03357848
NCT03357848UnknownNot Applicable

Impact of Caloric and Protein Adequacy on Postoperative Clinical Outcomes of Patients Undergoing Major Abdominal Surgery

Federal University of Minas Gerais1 site in 1 country60 target enrollmentStarted: December 19, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Postoperative complications

Study Overview

Brief Summary

The role of nutritional therapy (TN) in the surgical patient is well described in the literature and is associated with reductions in postoperative complications, length of hospital stay, and mortality. Adequate determination of caloric and protein requirements is an essential step in the TN institution, avoiding hypoalimentation and hyperalimentation. Thus, it is essential to understand the changes in energy expenditure after surgery and its relation with nutritional status. In addition, little is known about the effect of nutritional therapy and caloric adequacy on parameters such as phase angle and dynamometry. Thus, the objective of this study is to evaluate the changes in energy expenditure after major abdominal surgeries and to evaluate the phase angle and dynamometry as possible markers of nutritional therapy. Energy expenditure will be assessed by indirect calorimetry. Functionality will be assessed by means of dynamometry and 6-minute walk test. Nutritional diagnosis will be given through subjective global assessment. Energy and protein intake will be monitored and registered daily. Phase angle will be obtained by performing bioelectrical impedance.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Over 18 years old
  • Patients admitted for major abdominal surgery
  • Sign the consent form

Exclusion Criteria

  • Length of hospital stay less than 3 days
  • Pregnancy
  • Patients who, for any reason, can not perform indirect calorimetry

Outcomes

Primary Outcomes

Postoperative complications

Time Frame: 30 days after surgery

According to the Dindo-Clavien protocol

Secondary Outcomes

  • Phase angle(24 hours pre-surgery, 3 and 7 days after surgery)
  • Body composition(24 hours pre-surgery, 3 and 7 days after surgery)
  • Nutritional status(24 hours pre-surgery and 7 days after surgery)
  • Functional status(24 hours pre-surgery, 3 and 7 days after surgery)
  • Energy expenditure(3, 5 and 7 days after surgery)

Investigators

Sponsor
Federal University of Minas Gerais
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maria Isabel Toulson Davisson Correia

Professor/ Nutrition Service Coordinator

Federal University of Minas Gerais

Study Sites (1)

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