Impact of Iron Deficiency on the Incidence of Postoperative Infections (CARIPO)

Impact of Iron Deficiency on the Incidence of Postoperative Infections - CARIPO Observational Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Complications; Iron-deficiency; Postoperative Infection
• Intervention / Treatment: Other: no intervention, but presence of ID or not

Detailed Description

Postoperative infections are one of the most common complication after surgery, involving 2 to 50% of patients according to series and representing 16% of healthcare associated infections. Postoperative infections are highly morbid and result in a significant cost for the society, by increasing the length of hospital stay for example. They also have an impact on bacterial ecology because of the use of broad-spectrum antibiotic therapy to treat nosocomial infection. The decrease of postoperative infections occurrence is a major public health challenge.

Iron deficiency, with or without iron-deficiency anemia, is also very common during the perioperative period. Its prevalence goes from 30 to 40% and even up to 60% when associated with anemia. Iron deficiency is associated with an increased morbidity and mortality. Indeed, iron is a mineral element essential for oxygen transport through hemoglobin, but also implied in cellular metabolism by its role in the electron transport chain and in the citric acid cycle in the mitochondrion. Hence, iron is essential for the proper functioning of the immune system. Iron deficiency leads to an alteration of cellular immune defenses with a decrease in neutrophils function secondary to reduced myeloperoxidase activity, an alteration of their phagocytic capacity, a decrease in the number of T lymphocytes and a weaker response to antigenic exposure, an alteration of Natural Killer lymphocytes activity and a lower interleukine-2 production by lymphocytes. Thus, iron deficiency was associated with an increased risk of sepsis in human.

According to an old cohort published in 1988, a preoperative iron deficiency (defined by ferritin ≤20 ng/L) on 448 patients who underwent abdominal surgery, was associated with an increased in postoperative infections (23 vs 5 infections, p<0,001) and with a longer hospital stay (12±4 vs 8±3 days, p<0,001). However, a recent prospective observational study (2018), regarding orthopedic elective surgery, iron deficiency was not associated with an increased perioperative morbidity nor mortality. The statistical power was limited (100 patients, whose 6 only with iron deficiency, postoperative infections are rare in elective orthopedic surgery and assessed at day 30 instead of day 90 as recommended).

Accordingly, data from literature do not allow us to conclude on how perioperative iron deficiency influences postoperative infections occurrence. Yet, patients might benefit from preoperative iron supplementation. The PREVENTT randomized controlled trial, published in October 2020, studied the impact of intravenous iron supplementation before major abdominal surgery for anemic patients. This trial found a statistically significant decrease in hospital readmission in the treatment group and a downward trend in the occurrence of postoperative infections. Similar results were highlighted in 2016 in a randomized controlled trial comparing the fate of patients according to iron supplementation or not immediately after surgery.

Those results invite to undertake further clinical studies to better characterize the impact of iron deficiency and its correction on postoperative infections occurrence.

Our first hypothesis is that preoperative iron deficiency would be associated with an increased incidence of postoperative infections after major surgery and that its correction would lessen this association.

• Study Type: Observational
• Enrollment (Actual): 413

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHU Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients admitted to undergo a major elective surgery

Other: no intervention, but presence of ID or not; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
To assess the incidence of overall postoperative complications according to the iron-stock status	Postoperative complications are assessed by the POMS (Postoperative Morbidity Survey)	90 days

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): August 12, 2022
• Study Completion (Anticipated): January 15, 2023

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: infection; postoperative; major surgery; iron-deficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Infections; Communicable Diseases; Anemia, Iron-Deficiency; Postoperative Complications
• Other Study ID Numbers: 202100105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No