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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03357848
• Other study ID #: CAAE-12279713.1.0000.5149
• Status: Recruiting
• Phase: N/A
• First received: November 22, 2017
• Last updated: November 29, 2017
• Start date: December 19, 2016
• Est. completion date: August 2018

Study information

• Verified date: November 2017
• Source: Federal University of Minas Gerais
• Contact: Maria Isabel TD Correia, PHD
• Phone: +55 31 991688239
• Email: isabel_correia[@]uol.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Energy Supply; Deficiency
• Postoperative Complications
• Protein-Energy Malnutrition
• Surgery

Locations

Country	Name	City	State
Brazil	Hospital of Clinics of the University Federal of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	According to the Dindo-Clavien protocol	30 days after surgery
Secondary	Phase angle	Changes in phase angle after surgery as measured by bioelectrical impedance	24 hours pre-surgery, 3 and 7 days after surgery
Secondary	Body composition	Changes in body composition after surgery as measured by bioelectrical impedance	24 hours pre-surgery, 3 and 7 days after surgery
Secondary	Nutritional status	Changes in nutritional status after surgery as assessed by subjective global assessment (SGA)	24 hours pre-surgery and 7 days after surgery
Secondary	Functional status	Changes in functional status after surgery as assessed by hand grip strength	24 hours pre-surgery, 3 and 7 days after surgery
Secondary	Energy expenditure	Changes in energy expenditure after surgery measured by indirect calorimetry	3, 5 and 7 days after surgery