Preoperative Carbohydrate Loading in Elective Surgery (PROCY)

PREOPERATIVE ORAL CARBOHYDRATE LOADING: EFFECTS ON THE GLUCOSE METABOLISM AND POSTOPERATIVE INFECTIONS

Postoperative infectious morbidity remain the most frequent, threatening and costly event after major surgery. Maintenance of postoperative euglycemia might be a key factor to prevent such complications and given the preliminary data on the positive effect of carbohydrate load on glucose metabolism it might also be valuable in improving outcome. If this treatment will be proved effective on relevant outcome measure such as rate of infections, it might be used routinely and extensively because preoperative carbohydrates administration is cheap, simple and applicable by everyone in any surgical ward.

The aim of the trial is to evaluate if the normalization of blood glucose by means of preoperative oral administration of maltodextrine, in patients candidate to elective major surgery, may be effective in improve surgical morbidity.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Dietary supplement: PREOP; Other: water

• Study Type: Interventional
• Enrollment (Actual): 880
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Monza, Italy, 20052
    • San Gerardo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients candidate for elective major (expected duration > 2 hrs) abdominal, urologic, and gynecologic surgery

Exclusion Criteria:

• diagnosis of diabetes mellitus,
• baseline plasma glucose level > 125 mg/dl,
• pancreatic resection,
• ASA score > 3,
• malnutrition (loss of weight greater than 10%),
• emergency surgery,
• documented gastro-esophageal reflux,
• corticosteroid therapy,
• ongoing infection,
• pregnancy,
• age < 18 years,
• denied written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: preoperative carbohydrate loading; Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrine; 240 mOsm/L) in dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia	Dietary supplement: PREOP; a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrine; 240 mOsm/L) in dose of 800 mL
Placebo Comparator: water; The control group will receive plain water with the same volume and timing of treatment.	Other: water; The control group will receive plain water with the same volume and timing of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of postoperative complications	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
rate of patients needing insulin treatment	4 days
rate of total complications	30 day after surgery
rate of patients needing antibiotic therapy	30 days after surgery
rate of reopaeration	15 days
rate of patients needing intensive care treatment	15 days
length of hospital stay	15 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
At least one postoperative measurement of blood glucose > 110 mL/dL e < 140		15 days
At least one postoperative measurement of blood glucose > 140 mL/dL e < 180		15 days
Severity of complications	grading according to Clavien	30 days
Duration of intensive care treatment		15 days
Duration of overall complications		30 days
Duration of antibiotic therapy		30 days

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Collaborators: University of Pavia; European Institute of Oncology; University of Siena; San Raffaele University Hospital, Italy
• Investigators: Principal Investigator: Luca Gianotti, MD, PhD, Milano-Bicocca University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 20, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Estimate): August 8, 2016
• Last Update Submitted That Met QC Criteria: August 5, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: glucose metabolism; carbohydrate; urology; surgery, outcome; major elective surgery; hyperglicemia
• Other Study ID Numbers: PROCY; SIS-E (Other Grant/Funding Number: SIS-E)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES