CClinicalTrials.gg
Status unknownNCT03903354Updated Apr 5, 2019

Intraoperative Hyperglycemia and Infections After Orthopedic Surgery

An observational study in Severe Hyperglycemia, Postoperative Infection and Orthopedic Patients, sponsored by Federico Bilotta. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2019-04-05.

Sponsored by Federico Bilotta · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
All
01

Study summary

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).

02

Conditions studied

  • Severe Hyperglycemia
  • Postoperative Infection
  • Orthopedic Patients
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

This is the only study on the registry with Federico Bilotta as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

We are enrolling orthopedic patients undergoing surgery.

Inclusion criteria

  • Orthopedic patients

Exclusion criteria

Exclusion Criteria:

  • Non-orthopedic patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
8 Days
Patient registry
Yes

Interventions

  • OtherIncidence of infections within 7 days postoperatively

    Measure blood glucose concentration intraoperatively and evaluate incidence of infections 7 days after surgery

06

What researchers measure

Primary outcomes

  1. Severe hyperglycemia and incidence of infection

    Evaluate the relationship between intraoperative severe hyperglycemia and incidence of infections at 7 days follow up.

    Time frame: Follow up of the patients for 7 days postoperatively

07

Study locations

1 of 1 sites recruiting
  • Sapienza
    Roma, RM 00161, Italy
    • Federico Bilotta, M.D., Ph.D. · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03903354
Lead sponsor
Federico Bilotta
Responsible party
Federico Bilotta (Clinical professor, University of Roma La Sapienza) — Sponsor-investigator
First posted
Apr 4, 2019
Start date
Jan 13, 2018
Primary completion
Apr 13, 2018
Completion
Nov 2019 (estimated)
Last update
Apr 5, 2019

Study contacts

Federico Bilotta, M.D., Ph.D.
Contact
bilotta@tiscali.it
3393370822

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion