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| ID | Type | Description | Link |
|---|---|---|---|
| SIS-E | Other Grant/Funding Number | SIS-E |
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| Name | Class |
|---|---|
| European Institute of Oncology | OTHER |
| San Raffaele University Hospital, Italy | OTHER |
| University of Siena | OTHER |
| University of Pavia |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| water | Placebo Comparator | The control group will receive plain water with the same volume and timing of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of postoperative complications | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| rate of patients needing insulin treatment | 4 days | |
| rate of total complications | 30 day after surgery | |
| rate of patients needing antibiotic therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| luca gianotti, MD, PhD | Milano-Bicocca University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San gerardo hospital | Monza | 20052 | Italy |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| OTHER |
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| water | Other | The control group will receive plain water with the same volume and timing of treatment. |
|
| 30 days after surgery |
| rate of reopaeration | 15 days |
| rate of patients needing intensive care treatment | 15 days |
| length of hospital stay | 15 days |
| Severity of complications |
grading according to Clavien |
| 30 days |
| Duration of intensive care treatment | 15 days |
| Duration of overall complications | 30 days |
| Duration of antibiotic therapy | 30 days |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |