Preoperative Carbohydrate Loading in Elective Surgery

Surgery Clinical Trial

— PROCY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167387
• Other study ID #: PROCY
• Secondary ID: SIS-E
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2010
• Last updated: August 5, 2016
• Start date: January 2011
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 100 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Surgery

Intervention

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

Other:
• water
The control group will receive plain water with the same volume and timing of treatment.

Locations

Country	Name	City	State
Italy	San gerardo hospital	Monza

Sponsors (5)

Lead Sponsor	Collaborator
University of Milano Bicocca	European Institute of Oncology, San Raffaele University Hospital, Italy, University of Pavia, University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	At least one postoperative measurement of blood glucose > 110 mL/dL e < 140		15 days	No
Other	At least one postoperative measurement of blood glucose > 140 mL/dL e < 180		15 days	Yes
Other	Severity of complications	grading according to Clavien	30 days	No
Other	Duration of intensive care treatment		15 days	No
Other	Duration of overall complications		30 days	No
Other	Duration of antibiotic therapy		30 days	No
Primary	rate of postoperative complications		30 days	Yes
Secondary	rate of patients needing insulin treatment		4 days	No
Secondary	rate of total complications		30 day after surgery	No
Secondary	rate of patients needing antibiotic therapy		30 days after surgery	No
Secondary	rate of reopaeration		15 days	No
Secondary	rate of patients needing intensive care treatment		15 days	No
Secondary	length of hospital stay		15 days	No