Carbohydrates and Proteins 3h Before Surgery

NCT01563965 | Completed Phase 3 DMC

• 2 other identifiers: pexe_aguilar471206/2009-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Prolonged pre-operative fasting increases postoperative hospital stay and current evidence recommends carbohydrate (CHO) drinks 2 hours before surgery. Our hypothesis is that the addition of hydrolized protein to a CHO-based drink not only reduces the inflammatory response but also diminish hospitalization.

Conditions

Surgery; Postoperative Complications; Inflammation

Keywords

Preoperative fasting; Acute phase proteins; Carbohydrates; Protein hydrolizate; Inflammatory response; Surgery

Outcome Measures

Primary Outcomes (1)

• Length of postoperative hospital stay

  We compared the length of hospital postoperative stay in the 2 groups of the study.

  12 months

Secondary Outcomes (1)

• Inflammatory markers

  12 months

Study Arms (2)

Conventional preoperative fast

ACTIVE COMPARATOR

Patients underwent surgery after 8h fast

Other: Preoperative fasting of 8h

Carbohydrate plus protein beverage

EXPERIMENTAL

The study group received 400 ml (evening drink) or 200 ml (3h prior to operation drink) of a solution containing 11% de protein (pea hydrolized proptein), 89% de carbohydrates (maltodextrin 79% and saccharose 21%) e 0% of lipids (Providextra, Fresenius Kabi, São Paulo, Brasil).All the patients fasted for solids at least 8 hours from the operation

Dietary Supplement: Carbohydrate plus hydrolyzed protein beverage

Interventions

Carbohydrate plus hydrolyzed protein beverage DIETARY_SUPPLEMENT

The study group received 400 ml (evening drink) or 200 ml (3h prior to operation drink) of a solution containing 11% de protein (pea hydrolized proptein), 89% de carbohydrates (maltodextrin 79% and saccharose 21%) e 0% of lipids (Providextra, Fresenius Kabi, São Paulo, Brasil). All the patients fasted for solids at least 6 hours from the operation

Also known as: Providextra, Fresenius Kabi, São Paulo, Brasil

Carbohydrate plus protein beverage

Preoperative fasting of 8h OTHER

Conventional protocol of 8h fasting before an operation

Also known as: Control group

Conventional preoperative fast

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18-65 years-old),
• of both sexes, and candidates to elective major operations such as subtotal gastrectomy, colectomy, and anterior resection of the rectum for malignancies

You may not qualify if:

• Diabetes mellitus,
• chronic kidney failure,
• chronic liver disease or serum bilirubin greater than 2 mg/dL,
• body mass index (BMI) above 35Kg/m2, American Anesthesiologists Association (ASA) score above 3,
• gastro-esophageal reflux,
• gastroparesis or intestinal obstruction.
• Patients with any non-compliance with the study protocol, or who had associated operations, or presented severe intraoperative complications (any type of shock, cardiac arrest, coagulations problems), or experienced prolonged

Sponsors & Collaborators

• Federal University of Mato Grosso: lead

Study Sites (1)

Hospital Universitario Julio Mullar

Cuiabá, Mato Grosso, 78000-000, Brazil

Location

Related Publications (3)

• Dock-Nascimento DB, de Aguilar-Nascimento JE, Magalhaes Faria MS, Caporossi C, Slhessarenko N, Waitzberg DL. Evaluation of the effects of a preoperative 2-hour fast with maltodextrine and glutamine on insulin resistance, acute-phase response, nitrogen balance, and serum glutathione after laparoscopic cholecystectomy: a controlled randomized trial. JPEN J Parenter Enteral Nutr. 2012 Jan;36(1):43-52. doi: 10.1177/0148607111422719.

  PMID: 22235107 BACKGROUND

• Perrone F, da-Silva-Filho AC, Adorno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao A, de Aguilar-Nascimento JE. Effects of preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J. 2011 Jun 13;10:66. doi: 10.1186/1475-2891-10-66.

  PMID: 21668975 BACKGROUND

• de Aguilar-Nascimento JE, Dock-Nascimento DB. Reducing preoperative fasting time: A trend based on evidence. World J Gastrointest Surg. 2010 Mar 27;2(3):57-60. doi: 10.4240/wjgs.v2.i3.57.

  PMID: 21160851 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Inflammation

Interventions

Carbohydrates; Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jose E Aguilar-Nascimento, MD, PhD

  University of Mato Grosso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 24, 2012
• First Posted: March 27, 2012
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 27, 2012

Record last verified: 2012-03

Locations

BR (1)