Clinical trial NCT01167387: Preoperative Carbohydrate Loading in Elective Surgery
Official title: PREOPERATIVE ORAL CARBOHYDRATE LOADING: EFFECTS ON THE GLUCOSE METABOLISM AND POSTOPERATIVE INFECTIONS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgery
Keywords: carbohydrate
glucose metabolism
surgery, outcome
major elective surgery
urology
hyperglicemia
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: European Institute of Oncology
name: San Raffaele University Hospital, Italy
name: University of Siena
name: University of Pavia
First posted: 2010-07-22
Enrollment: 880
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: rate of postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: rate of patients needing insulin treatment
timeFrame: 4 days
measure: rate of total complications
timeFrame: 30 day after surgery
measure: rate of patients needing antibiotic therapy
timeFrame: 30 days after surgery
measure: rate of reopaeration
timeFrame: 15 days
measure: rate of patients needing intensive care treatment
timeFrame: 15 days
measure: length of hospital stay
timeFrame: 15 days
Other outcomes:
measure: At least one postoperative measurement of blood glucose > 110 mL/dL e < 140
timeFrame: 15 days
measure: At least one postoperative measurement of blood glucose > 140 mL/dL e < 180
timeFrame: 15 days
measure: Severity of complications
timeFrame: 30 days
measure: Duration of intensive care treatment
timeFrame: 15 days
measure: Duration of overall complications
timeFrame: 30 days
measure: Duration of antibiotic therapy
timeFrame: 30 days
Locations:
city: Monza
country: Italy
facility: San gerardo hospital
Study officials:
affiliation: Milano-Bicocca University
name: luca gianotti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: