Severe HyperglycemiaNCT03903354
Intraoperative Hyperglycemia and Infections After Orthopedic Surgery
An observational study of Severe Hyperglycemia and Postoperative Infection, run by Federico Bilotta at 1 site in Italy.
Trial summary
Postoperative infections are a common complication. A relationship between perioperative severe hyperglycemia and postoperative infections has been found in patients undergoing craniotomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Hyperglycemia, Postoperative Infection, Orthopedic Patients
- What is being tested?
- Incidence of infections within 7 days postoperatively
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jan 2018to Nov 2019
- How long will I take part?
- 8 Days
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We are enrolling orthopedic patients undergoing surgery.
Who may be able to join
- Orthopedic patients
Who cannot join
- Non-orthopedic patients
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Sapienza
Roma, RM, 00161
Federico Bilotta, M.D., Ph.D.
About this study
Official title: Relationship Between Severe Intraoperative Hyperglycemia and Infections Within 7 Days After Orthopedic Surgery
Postoperative infections are a common complication. A relationship between perioperative severe hyperglycemia and postoperative infections has been found in patients undergoing craniotomy. The aim of this study is to evaluate the epidemiology of intraoperative severe hyperglycemia (BGC >180 mg/dL; 10 mmol/L) and postoperative infections (wound, urinary and prosthetic joint infection) and to investigate if severe intraoperative hyperglycemia is associated with an higher risk of early postoperative (within the 7th postoperative days) infections (wound, urinary and prosthetic joint infection).
- Being tested
- Incidence of infections within 7 days postoperatively
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incidence of infections within 7 days postoperativelyOther
Measure blood glucose concentration intraoperatively and evaluate incidence of infections 7 days after surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe hyperglycemia and incidence of infection
Evaluate the relationship between intraoperative severe hyperglycemia and incidence of infections at 7 days follow up.
Measured: Follow up of the patients for 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start13 Jan 2018
- Primary completion13 Apr 2018
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe HyperglycemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 8 Days
Sponsor and investigators
- Lead sponsor
- Federico Bilotta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Federico Bilotta, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903354
- Sponsor's protocol ID
- Hypergly&Infect Orth patient
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Severe Intraoperative Hyperglycemia and Infections Within 7 Days After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT03903354
- Acronym / sponsor ID
- Hypergly&Infect Orth patient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Federico BilottaUniversity, hospital or other
- Study start
- 13 Jan 2018 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- Nov 2019 (estimated)
- First posted
- 4 Apr 2019 (actual)
- 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 infections are a common complication. A relationship between perioperative severe hyperglycemia and postoperative infections has been found in patients undergoing craniotomy. The aim of this study is to evaluate the epidemiology of intraoperative severe hyperglycemia (BGC >180 mg/dL; 10 mmol/L) and postoperative infections (wound, urinary and prosthetic joint infection) and to investigate if severe intraoperative hyperglycemia is associated with an higher risk of early postoperative (within the 7th postoperative days) infections (wound, urinary and prosthetic joint infection).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We are enrolling orthopedic patients undergoing surgery.
Key inclusion criteria (1 listed)
- Orthopedic patients
Key exclusion criteria (1 listed)
- Non-orthopedic patients
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 |
|---|---|---|
| Incidence of infections within 7 days postoperativelyMeasure blood glucose concentration intraoperatively and evaluate incidence of infections 7 days after surgery | Other | – |
Primary outcome
Severe hyperglycemia and incidence of infection
Time frame: Follow up of the patients for 7 days postoperatively
Evaluate the relationship between intraoperative severe hyperglycemia and incidence of infections at 7 days follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Hyperglycemia and Postoperative Infection, run by Federico Bilotta 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 1 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: status not confirmed, as of the sponsor's last update on 5 Apr 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Bilotta, M.D., Ph.D. (3393370822, bilotta@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe hyperglycemia and incidence of infection (time frame: Follow up of the patients for 7 days postoperatively). 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 5 Apr 2019.