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OpenTrials
Completed

NCT Number: NCT01167387

Preoperative Carbohydrate Loading in Elective Surgery

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.

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Key information

Conditions

Surgery

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San gerardo hospital

Monza, 20052, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PREOP

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

Other

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

Primary outcomes

  1. rate of postoperative complications

    Time frame: 30 days

Secondary outcomes

  1. rate of patients needing insulin treatment

    Time frame: 4 days

  2. rate of total complications

    Time frame: 30 day after surgery

  3. rate of patients needing antibiotic therapy

    Time frame: 30 days after surgery

  4. rate of reopaeration

    Time frame: 15 days

  5. rate of patients needing intensive care treatment

    Time frame: 15 days

  6. length of hospital stay

    Time frame: 15 days

Other outcomes

  1. At least one postoperative measurement of blood glucose > 110 mL/dL e < 140

    Time frame: 15 days

  2. At least one postoperative measurement of blood glucose > 140 mL/dL e < 180

    Time frame: 15 days

  3. Severity of complications

    Time frame: 30 days

    grading according to Clavien

  4. Duration of intensive care treatment

    Time frame: 15 days

  5. Duration of overall complications

    Time frame: 30 days

  6. Duration of antibiotic therapy

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Collaborators

  • European Institute of Oncology
  • San Raffaele University Hospital, Italy
  • University of Pavia
  • University of Siena

Registry information

Official study title

PREOPERATIVE ORAL CARBOHYDRATE LOADING: EFFECTS ON THE GLUCOSE METABOLISM AND POSTOPERATIVE INFECTIONS

Acronym: PROCY

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jul 22, 2010
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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