Carbohydrates and Proteins 3h Before Surgery
Primary Purpose
Surgery, Postoperative Complications, Inflammation
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Carbohydrate plus hydrolyzed protein beverage
Preoperative fasting of 8h
Sponsored by
About this trial
This is an interventional treatment trial for Surgery focused on measuring Preoperative fasting, Acute phase proteins, Carbohydrates, Protein hydrolizate, Inflammatory response, Surgery
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
Sites / Locations
- Hospital Universitario Julio Mullar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional preoperative fast
Carbohydrate plus protein beverage
Arm Description
Patients underwent surgery after 8h fast
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
Outcomes
Primary Outcome Measures
Length of postoperative hospital stay
We compared the length of hospital postoperative stay in the 2 groups of the study.
Secondary Outcome Measures
Inflammatory markers
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
Full Information
NCT ID
NCT01563965
First Posted
March 24, 2012
Last Updated
March 26, 2012
Sponsor
Federal University of Mato Grosso
1. Study Identification
Unique Protocol Identification Number
NCT01563965
Brief Title
Carbohydrates and Proteins 3h Before Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Mato Grosso
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Postoperative Complications, Inflammation
Keywords
Preoperative fasting, Acute phase proteins, Carbohydrates, Protein hydrolizate, Inflammatory response, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional preoperative fast
Arm Type
Active Comparator
Arm Description
Patients underwent surgery after 8h fast
Arm Title
Carbohydrate plus protein beverage
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate plus hydrolyzed protein beverage
Other Intervention Name(s)
Providextra, Fresenius Kabi, São Paulo, Brasil
Intervention Description
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
Other
Intervention Name(s)
Preoperative fasting of 8h
Other Intervention Name(s)
Control group
Intervention Description
Conventional protocol of 8h fasting before an operation
Primary Outcome Measure Information:
Title
Length of postoperative hospital stay
Description
We compared the length of hospital postoperative stay in the 2 groups of the study.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Inflammatory markers
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose E Aguilar-Nascimento, MD, PhD
Organizational Affiliation
University of Mato Grosso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Julio Mullar
City
Cuiaba
State/Province
Mato Grosso
ZIP/Postal Code
78000-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
22235107
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.
Results Reference
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PubMed Identifier
21668975
Citation
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.
Results Reference
background
PubMed Identifier
21160851
Citation
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.
Results Reference
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