Preoperative Carbohydrate Loading in Elective Surgery

NCT ID: NCT01167387

Last Updated: 2016-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 880 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-03-31

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.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

preoperative carbohydrate loading

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

Group Type: EXPERIMENTAL

PREOP

Intervention Type: DIETARY_SUPPLEMENT

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

water

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

Group Type: PLACEBO_COMPARATOR

water

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

water

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: collaborator

San Raffaele University Hospital, Italy

OTHER

Sponsor Role: collaborator

University of Siena

OTHER

Sponsor Role: collaborator

University of Pavia

OTHER

Sponsor Role: collaborator

University of Milano Bicocca

OTHER

Sponsor Role: lead

Responsible Party

Luca Vittorio Gianotti

professor of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

luca gianotti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Milano-Bicocca University

Locations

San gerardo hospital

Monza, , Italy

Countries

Italy

Other Identifiers

SIS-E

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PROCY

Identifier Type: -

Identifier Source: org_study_id