Carbohydrates and Proteins 3h Before Surgery

NCT ID: NCT01563965

Last Updated: 2012-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-12-31

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.

Detailed Description

This was a randomized, double-blind, clinical study carried out at the Julio Muller University Hospital (Mato Grosso State, Brazil). The study was approved by the hospital Research Ethics Committee registered under number 723/CEP-HUJM/09 and is in accordance with the ethics principals set out in the Helsinki Declaration (2000), and meets Brazilian national legal specifications.

Inclusion criteria includes 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. Exclusion criteria were having 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 operations (lasting more than 6 hours) were also excluded.

Patient randomization was carried out on admission to the hospital using random numbers issued by a computer program (www.graphpad.com). For the randomization the precepts of the CONSORT flow diagram were followed.

The patients were randomized into two groups: the study group and the control group. The patients were given a specific drink to their group on the evening prior to surgery and three hours before the operation. 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) and the control group received conventional 6-8h fast. All the patients fasted for solids at least 6 hours from the operation.

On the day before the surgery and on the second postoperative day blood samples were collected for glucose, insulin, triglycerides, albumin, pre-albumin, CRP, and α-1-acid glycoprotein (α-1-GA) assays. The HOMA-IR (Homeostasis Model Assessment-Insulin Resistance) equation was used to assess insulin resistance according to the formula: HOMA-IR = insulin (µU/mL) x glycaemia (mg/dL) / 405. To assess inflammatory activity the PINI (CRP (mg/L) x α-1-GA (mg/L)/ albumin (g/L) x pre-albumin (mg/L) and the CRP/albumin ratio were used.

The mean outcome variable was the length of postoperative stay. Other endpoints included the infectious morbidity, the insulin resistance assessed by HOMA-IR, and the inflammatory indexes or markers mentioned above.

Conditions

Surgery; Postoperative Complications; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional preoperative fast

Patients underwent surgery after 8h fast

Group Type: ACTIVE_COMPARATOR

Preoperative fasting of 8h

Intervention Type: OTHER

Conventional protocol of 8h fasting before an operation

Carbohydrate plus protein beverage

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

Group Type: EXPERIMENTAL

Carbohydrate plus hydrolyzed protein beverage

Intervention Type: 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

Interventions

Carbohydrate plus hydrolyzed protein beverage

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

Intervention Type: DIETARY_SUPPLEMENT

Preoperative fasting of 8h

Conventional protocol of 8h fasting before an operation

Intervention Type: OTHER

Other Intervention Names

Providextra, Fresenius Kabi, São Paulo, Brasil; Control group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Mato Grosso

OTHER

Sponsor Role: lead

Responsible Party

Jose Eduardo de Aguilar-Nascimento

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose E Aguilar-Nascimento, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Mato Grosso

Locations

Hospital Universitario Julio Mullar

Cuiabá, Mato Grosso, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 22235107 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21668975 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21160851 (View on PubMed)

Other Identifiers

471206/2009-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

pexe_aguilar

Identifier Type: -

Identifier Source: org_study_id