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Preoperative Carbohydrate Loading in Elective Surgery

NCT01167387 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2016-08-08

No results posted yet for this study

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

Interventions

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 800 mL

OTHER

water

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

Sponsors & Collaborators

  • European Institute of Oncology

    collaborator OTHER

  • San Raffaele University Hospital, Italy

    collaborator OTHER

  • University of Siena

    collaborator OTHER

  • University of Pavia

    collaborator OTHER

  • University of Milano Bicocca

    lead OTHER

Principal Investigators

  • luca gianotti, MD, PhD · Milano-Bicocca University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01167387 on ClinicalTrials.gov