Preoperative Carbohydrate Loading in Elective Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Milano Bicocca.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
European Institute of Oncology
Information provided by:
University of Milano Bicocca
ClinicalTrials.gov Identifier:
NCT01167387
First received: July 20, 2010
Last updated: July 21, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Elective Surgery
Abdominal Surgery
Thoracic Surgery
Gynecological Surgery
Dietary Supplement: PREOP
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PREOPERATIVE ORAL CARBOHYDRATE LOADING: EFFECTS ON THE GLUCOSE METABOLISM AND POSTOPERATIVE INFECTIONS

Further study details as provided by University of Milano Bicocca:

Primary Outcome Measures:
  • rate of postoperative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 660
Study Start Date: June 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: preoperative carbohydrate loading
Patients in the treatment group (n=330) 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 600-800 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 600-800 mL
Placebo Comparator: water
The control group (n=330) will receive plain water with the same volume and timing of treatment.
Other: placebo
The control group (n=330) will receive plain water with the same volume and timing of treatment.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

diagnosis of diabetes mellitus, baseline plasma glucose level > 125 mg/dl, pancreatoduodenectomy, 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167387

Locations
Italy
San gerardo hospital Recruiting
Monza, Italy, 20052
Contact: luca gianotti, MD, PhD    +39-039-2332391    luca.gianotti@unimib.it   
Principal Investigator: luca gianotti, MD, PhD         
Sub-Investigator: luca nespoli, MD         
Sponsors and Collaborators
University of Milano Bicocca
European Institute of Oncology
Investigators
Principal Investigator: luca gianotti, MD, PhD Milano-Bicocca University
  More Information

No publications provided

Responsible Party: Luca Gianotti, Milano-Bicocca University
ClinicalTrials.gov Identifier: NCT01167387     History of Changes
Other Study ID Numbers: PROCI, SIS
Study First Received: July 20, 2010
Last Updated: July 21, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by University of Milano Bicocca:
carbohydrate
glucose metabolism
surgery, outcome
major elective surgery
urology

ClinicalTrials.gov processed this record on September 16, 2014