SurgeryPhase 3PROCYNCT01167387
Preoperative Carbohydrate Loading in Elective Surgery
A Phase 3 study testing PREOP and water in people with Surgery, run by University of Milano Bicocca at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Surgery
- What is being tested?
- PREOP and water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 880 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients candidate for elective major (expected duration > 2 hrs) abdominal, urologic, and gynecologic surgery
Who cannot join
- 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,
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- documented gastro-esophageal reflux,
- corticosteroid therapy,
- ongoing infection,
- pregnancy,
- age < 18 years,
- denied written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREOPERATIVE ORAL CARBOHYDRATE LOADING: EFFECTS ON THE GLUCOSE METABOLISM AND POSTOPERATIVE INFECTIONS
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
- Being tested
- PREOP, water
- Keywords
- carbohydrate, glucose metabolism, surgery, outcome, major elective surgery, urology, hyperglicemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
waterOther
The control group will receive plain water with the same volume and timing of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: PREOP |
| water | Placebo comparator | The control group will receive plain water with the same volume and timing of treatment. Receives: Other: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of postoperative complications
Measured: 30 days
Secondary outcomes (6)
rate of patients needing insulin treatment
Measured: 4 days
rate of total complications
Measured: 30 day after surgery
rate of patients needing antibiotic therapy
Measured: 30 days after surgery
rate of reopaeration
Measured: 15 days
rate of patients needing intensive care treatment
Measured: 15 days
length of hospital stay
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 880 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- European Institute of Oncology, San Raffaele University Hospital, Italy, University of Siena, University of Pavia
- Responsible party
- Principal investigator, Luca Vittorio Gianotti, University of Milano Bicocca
- Investigators
- luca gianotti, MD, PhD, Principal investigator, Milano-Bicocca University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167387
- Sponsor's protocol ID
- PROCY
- Other IDs
- SIS-E
- Acronym
- PROCY
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2010
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREOPERATIVE ORAL CARBOHYDRATE LOADING: EFFECTS ON THE GLUCOSE METABOLISM AND POSTOPERATIVE INFECTIONS
- ClinicalTrials.gov ID
- NCT01167387
- Acronym / sponsor ID
- PROCY / PROCY
- Conditions
- Surgery
- Keywords
- carbohydrate, glucose metabolism, surgery, outcome, major elective surgery, urology, hyperglicemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 880 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- European Institute of Oncology, San Raffaele University Hospital, Italy, University of Siena, University of Pavia
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative carbohydrate loading | Experimental | Dietary Supplement: PREOPPatients 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 | Other: waterThe control group will receive plain water with the same volume and timing of treatment. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients candidate for elective major (expected duration > 2 hrs) abdominal, urologic, and gynecologic surgery
Key exclusion criteria (12 listed)
- diagnosis of diabetes mellitus,
- baseline plasma glucose level > 125 mg/dl,
- pancreatic resection,
- ASA score > 3,
- malnutrition (loss of weight greater than 10%),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREOPa 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 | Dietary supplement | preoperative carbohydrate loading |
| waterThe control group will receive plain water with the same volume and timing of treatment. | Other | water |
Primary outcome
rate of postoperative complications
Time frame: 30 days
6 secondary outcomes
rate of patients needing insulin treatment
Time frame: 4 days
rate of total complications
Time frame: 30 day after surgery
rate of patients needing antibiotic therapy
Time frame: 30 days after surgery
rate of reopaeration
Time frame: 15 days
rate of patients needing intensive care treatment
Time frame: 15 days
length of hospital stay
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
luca gianotti, MD, PhD principal investigator
Milano-Bicocca University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PREOP and water in people with Surgery, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of postoperative complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.