Preoperative Carbohydrate Loading in Elective Surgery (PROCY)

University of Milano Bicocca

Status and phase: Completed; Phase 3

Conditions: Surgery

Treatments: Dietary Supplement: PREOP; Other: water

Study type: Interventional

Funder types: Other

Identifiers

NCT01167387

PROCY

SIS-E (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 880 patients

Sex: All

Ages: 19 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

880 participants in 2 patient groups, including a placebo group

preoperative carbohydrate loading

Experimental group

Description:

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

Treatment:

Dietary Supplement: PREOP

water

Placebo Comparator group

Description:

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

Treatment:

Other: water