NCT01167387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
880

participants targeted

Target at P75+ for phase_3 surgery

Timeline
Completed

Started Jan 2011

Typical duration for phase_3 surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

4.9 years

First QC Date

July 20, 2010

Last Update Submit

August 5, 2016

Conditions

Surgery

Keywords

carbohydrateglucose metabolismsurgery, outcomemajor elective surgeryurologyhyperglicemia

Outcome Measures

Primary Outcomes (1)

  • rate of postoperative complications

    30 days

Secondary Outcomes (6)

  • rate of patients needing insulin treatment

    4 days

  • rate of total complications

    30 day after surgery

  • rate of patients needing antibiotic therapy

    30 days after surgery

  • rate of reopaeration

    15 days

  • rate of patients needing intensive care treatment

    15 days

  • +1 more secondary outcomes

Other Outcomes (6)

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

    15 days

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

    15 days

  • Severity of complications

    30 days

  • +3 more other outcomes

Study Arms (2)

preoperative carbohydrate loading

EXPERIMENTAL

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

water

PLACEBO COMPARATOR

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

Other: water

Interventions

PREOPDIETARY_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

preoperative carbohydrate loading
waterOTHER

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

water

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San gerardo hospital

Monza, 20052, Italy

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • luca gianotti, MD, PhD

    Milano-Bicocca University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of surgery

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 22, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

IT(1)