Carbohydrates and Proteins 3h Before Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso do Sul
ClinicalTrials.gov Identifier:
NCT01563965
First received: March 24, 2012
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Surgery
Postoperative Complications
Inflammation
Dietary Supplement: Carbohydrate plus hydrolyzed protein beverage
Other: Preoperative fasting of 8h
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Federal University of Mato Grosso do Sul:

Primary Outcome Measures:
  • Length of postoperative hospital stay [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We compared the length of hospital postoperative stay in the 2 groups of the study.


Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    On the day before the surgery and on the second postoperative day blood samples were collected for albumin, pre-albumin, CRP, and α-1-acid glycoprotein (α-1-GA) assays. To assess inflammatory activity the prognostic inflammatory and nutritional index (PINI)(CRP (mg/L) x α-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


Enrollment: 30
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional preoperative fast
Patients underwent surgery after 8h fast
Other: Preoperative fasting of 8h
Conventional protocol of 8h fasting before an operation
Other Name: Control group
Experimental: 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
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 Name: Providextra, Fresenius Kabi, São Paulo, Brasil

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563965

Locations
Brazil
Hospital Universitario Julio Mullar
Cuiaba, Mato Grosso, Brazil, 78000-000
Sponsors and Collaborators
Federal University of Mato Grosso do Sul
Investigators
Principal Investigator: Jose E Aguilar-Nascimento, MD, PhD University of Mato Grosso
  More Information

Publications:
Responsible Party: Jose Eduardo de Aguilar-Nascimento, MD, PhD, Federal University of Mato Grosso do Sul
ClinicalTrials.gov Identifier: NCT01563965     History of Changes
Other Study ID Numbers: pexe_aguilar, 471206/2009-1
Study First Received: March 24, 2012
Last Updated: March 26, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Mato Grosso do Sul:
Preoperative fasting
Acute phase proteins
Carbohydrates
Protein hydrolizate
Inflammatory response
Surgery

Additional relevant MeSH terms:
Inflammation
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014