Carbohydrates and Proteins 3h Before Surgery

Surgery Clinical Trial

Official title:

Effects of the Abbreviation of Preoperative Fasting With Carbohydrates and Hydrolized Proteins on the Inflammatory Response and Insulin Resistance After Major Abdominal Operations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563965
• Other study ID #: pexe_aguilar
• Secondary ID: 471206/2009-1
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2012
• Last updated: March 26, 2012
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Federal University of Mato Grosso do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Postoperative Complications
• Surgery

Intervention

Dietary Supplement:
• 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

Other:
• Preoperative fasting of 8h
Conventional protocol of 8h fasting before an operation

Locations

Country	Name	City	State
Brazil	Hospital Universitario Julio Mullar	Cuiaba	Mato Grosso

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Mato Grosso do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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. — View Citation

Perrone F, da-Silva-Filho AC, Adôrno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damião 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of postoperative hospital stay	We compared the length of hospital postoperative stay in the 2 groups of the study.	12 months	No
Secondary	Inflammatory markers	On the day before the surgery and on the second postoperative day blood samples were collected for albumin, pre-albumin, CRP, and a-1-acid glycoprotein (a-1-GA) assays. To assess inflammatory activity the prognostic inflammatory and nutritional index (PINI)(CRP (mg/L) x a-1-GA (mg/L)/ albumin (g/L) x pre-albumin (mg/L) and the CRP/albumin ratio were calculated and used to compare the two groups	12 months	No