NCT03903354

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

April 2, 2019

Last Update Submit

April 3, 2019

Conditions

Severe HyperglycemiaPostoperative InfectionOrthopedic Patients

Outcome Measures

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.

    Follow up of the patients for 7 days postoperatively

Interventions

Incidence of infections within 7 days postoperativelyOTHER

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We are enrolling orthopedic patients undergoing surgery.

You may qualify if:

  • Orthopedic patients

You may not qualify if:

  • Non-orthopedic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza

Roma, RM, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Federico Bilotta, M.D., Ph.D.

CONTACT

3393370822bilotta@tiscali.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 4, 2019

Study Start

January 13, 2018

Primary Completion

April 13, 2018

Study Completion

November 1, 2019

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

IT(1)