Impact of Iron Deficiency on the Incidence of Postoperative Infections

NCT04994275 | Unknown

• 1 other identifier: 202100105
• Study Type: observational
• Target: 413
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency is a common state during the perioperative period. Data from literature do not allow us to conclude on how perioperative iron deficiency influences postoperative infections occurrence. This prospective observational study aims to assessed the postoperative infections incidence according to the preoperative iron-stock status.

Conditions

Iron-deficiency; Postoperative Complications; Postoperative Infection

Keywords

iron-deficiency; infection; postoperative; major surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative infectious complication

  The main goal of this study is to compare the incidence of postoperative infectious complications according to the preoperative patient's iron-stock status (supplemented or not). The primary outcome is the occurrence of at least one infection complication within 90 days after surgery. The various infections recorded are defined by the Center for disease control and prevention and included: * superficial surgical site infection (within 30 days after surgery) or deep surgical site infection (within 30 days after surgery or 90 days if an implant is in place) * pneumonia * urinary infection * bacteriemia * catheter infection

  90 days

Secondary Outcomes (3)

• To assess the prevalence of preoperative iron deficiency according to the surgical field

  Preoperative

• To assess the incidence of postoperative infections according to the type of surgery

  90 days

• To assess the incidence of overall postoperative complications according to the iron-stock status

  90 days

Study Arms (1)

Patients admitted to undergo a major elective surgery

Other: no intervention, but presence of ID or not

Interventions

no intervention, but presence of ID or not OTHER

This is an observational study regarding patients admitted to undergo a major elective surgery supposed to last more than an hour. Investigators will analyzed the incidence of postoperative infections up to 90 days after surgery according to the preoperative iron status: iron deficiency (defined as a ferritin of less than 100 µg/L or \<300 µg/L And TSAT\<20%) or no iron deficiency

Patients admitted to undergo a major elective surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult admitted to undergo elective surgery supposed to last more than an hour and who had an iron-deficiency assessment realized by blood sample as part of standard care

You may qualify if:

• Adult (≥ 18 years old)
• Iron-deficiency assessment realized by blood sample as part of standard care
• Elective surgery supposed to last more than an hour

You may not qualify if:

• Adult under tutelage
• Emergency surgery
• Refusal of data collection

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, France

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Postoperative Complications; Infections

Interventions

Nuclear Receptor Subfamily 4, Group A, Member 2

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orphan Nuclear Receptors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cytoplasmic and Nuclear

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: November 3, 2021
• Primary Completion: August 12, 2022
• Study Completion: January 15, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

FR (1)