Intraoperative Hyperglycemia and Infections After Orthopedic Surgery

April 3, 2019 updated by: Federico Bilotta

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00161
        • Recruiting
        • Sapienza
        • Contact:
          • Federico Bilotta, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We are enrolling orthopedic patients undergoing surgery.

Description

Inclusion Criteria:

  • Orthopedic patients

Exclusion Criteria:

  • Non-orthopedic patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Follow up of the patients for 7 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico Bilotta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2018

Primary Completion (Actual)

April 13, 2018

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hypergly&Infect Orth patient

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Infection

Clinical Trials on Incidence of infections within 7 days postoperatively

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe