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Preoperative Carbohydrate Loading in Elective Surgery (PROCY)

This study has been completed.
Sponsor:
Collaborators:
European Institute of Oncology
San Raffaele University Hospital, Italy
University of Siena
University of Pavia
Information provided by (Responsible Party):
Luca Vittorio Gianotti, University of Milano Bicocca
ClinicalTrials.gov Identifier:
NCT01167387
First received: July 20, 2010
Last updated: August 5, 2016
Last verified: August 2016
  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
Surgery
Dietary Supplement: PREOP
Other: water
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

Resource links provided by NLM:


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: Yes ]

Secondary Outcome Measures:
  • rate of patients needing insulin treatment [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • rate of total complications [ Time Frame: 30 day after surgery ] [ Designated as safety issue: No ]
  • rate of patients needing antibiotic therapy [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
  • rate of reopaeration [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • rate of patients needing intensive care treatment [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • length of hospital stay [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • At least one postoperative measurement of blood glucose > 110 mL/dL e < 140 [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • At least one postoperative measurement of blood glucose > 140 mL/dL e < 180 [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
  • Severity of complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    grading according to Clavien

  • Duration of intensive care treatment [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Duration of overall complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Duration of antibiotic therapy [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 880
Study Start Date: January 2011
Study Completion Date: March 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Placebo Comparator: water
The control group will receive plain water with the same volume and timing of treatment.
Other: water
The control group will receive plain water with the same volume and timing of treatment.

  Eligibility

Ages Eligible for Study:   19 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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
Monza, Italy, 20052
Sponsors and Collaborators
University of Milano Bicocca
European Institute of Oncology
San Raffaele University Hospital, Italy
University of Siena
University of Pavia
Investigators
Principal Investigator: luca gianotti, MD, PhD Milano-Bicocca University
  More Information

Responsible Party: Luca Vittorio Gianotti, professor of surgery, University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT01167387     History of Changes
Other Study ID Numbers: PROCY  SIS-E 
Study First Received: July 20, 2010
Last Updated: August 5, 2016
Health Authority: Italy: Ministry of Health
Individual Participant Data  
Plan to Share IPD: Yes

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

ClinicalTrials.gov processed this record on September 23, 2016