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

Sponsor

Federal University of Minas Gerais (Other)

Overall Status

Unknown status

CT.gov ID

NCT03357848

Collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais (Other), Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)

Enrollment

Location

19.4

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery Postoperative Complications Cancer Energy Supply; Deficiency

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 19, 2016

Anticipated Primary Completion Date :

Mar 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Study group Surgical patients receiving nutritional support (enteral and/or parenteral nutrition) pre and/or after surgery
Control group Surgical patients without nutritional support during the perioperative period

Outcome Measures

Primary Outcome Measures

Postoperative complications [30 days after surgery]
According to the Dindo-Clavien protocol

Secondary Outcome Measures

Phase angle [24 hours pre-surgery, 3 and 7 days after surgery]
Changes in phase angle after surgery as measured by bioelectrical impedance
Body composition [24 hours pre-surgery, 3 and 7 days after surgery]
Changes in body composition after surgery as measured by bioelectrical impedance
Nutritional status [24 hours pre-surgery and 7 days after surgery]
Changes in nutritional status after surgery as assessed by subjective global assessment (SGA)
Functional status [24 hours pre-surgery, 3 and 7 days after surgery]
Changes in functional status after surgery as assessed by hand grip strength
Energy expenditure [3, 5 and 7 days after surgery]
Changes in energy expenditure after surgery measured by indirect calorimetry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of Clinics of the University Federal of Minas Gerais	Belo Horizonte	Minas Gerais	Brazil

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Isabel Toulson Davisson Correia, Professor/ Nutrition Service Coordinator, Federal University of Minas Gerais

ClinicalTrials.gov Identifier:

NCT03357848

Other Study ID Numbers:

CAAE-12279713.1.0000.5149

First Posted:

Nov 30, 2017

Last Update Posted:

Nov 30, 2017

Last Verified:

Nov 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Postoperative Complications

Study Results

No Results Posted as of Nov 30, 2017