Preoperative Carbohydrate Loading in Elective Surgery

Phase 3

Completed

• Conditions: Surgery
• Interventions: Dietary Supplement: PREOP; Other: water

• Registration Number: NCT01167387
• Lead Sponsor: University of Milano Bicocca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Study Start: 2011-01
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-05
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 880

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preoperative carbohydrate loading	PREOP	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
water	water	The control group will receive plain water with the same volume and timing of treatment.

Primary Outcome Measures

Name	Time	Method
rate of postoperative complications	30 days

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	15 days
rate of patients needing intensive care treatment	15 days
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

Trial Locations

Locations (1)

San gerardo hospital; 🇮🇹 Monza, Italy