Iron Deficiency in Pediatric Heart Surgery

NCT06276608 | Recruiting

• 1 other identifier: PED_Fe_def
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of iron deficiency in pediatric cardiac surgery patients is not very well known. Iron deficiency can lead to anemia, higher transfusion rates and possibly higher complication rates. In this retrospective study, the iron status of all patients undergoing pediatric cardiac surgery at our institution between January 2019 and december 2023 will be analyzed. Together with iron status, transfusion requirements as well as complications will be recorded. Iron status will be reported with descriptive statistics, patients with or without iron deficiency will be compared using non-parametric tests.

Conditions

Iron Deficiencies; Iron Deficiency Anemia; Cardiac Surgical Procedures; Congenital Heart Disease in Children

Outcome Measures

Primary Outcomes (2)

• Prevalence of preoperative iron deficiency (%)

  A preoperative ferritin \< 10 mcg/L will be considered as iron deficiency. Iron deficiency will be reported using descriptive statistics (mean, standard deviation, median, interquartile range, %)

  24 hours

• Complications

  The complication rate (%) will be reported. Complications are defined by the occurence of one or more of the following events: * transfusion rate (%) * volume of packed red cells transfused (mL/kg) * perioperative blood loss (mL/kg) * need for surgical re-exploration (%) * intensive care stay (days) * new renal insufficiency (%) * use of inotropes (%) * 28 day mortality (%) The frequency of any single item will also be reported (%)

  28 days

Study Arms (1)

Pediatric cardiac surgery patients

All patients who underwent pediatric cardiac surgery in our institution between January 1, 2019 and december 31, 2023

Diagnostic Test: Iron status

Interventions

Iron status DIAGNOSTIC_TEST

Iron status will be based on preoperative ferritin levels: a ferritin \< 10 mcg/L will be considered as iron deficiency, ferritin levels \> 10 mcg/L will be considered normal

Pediatric cardiac surgery patients

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023

You may qualify if:

• All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023

You may not qualify if:

• Incomplete medical charts
• Patients who did not consent to the use of their medical data

Sponsors & Collaborators

• Queen Fabiola Children's University Hospital: lead

Study Sites (1)

H.U.B - Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

RECRUITING

Related Publications (4)

• Gao P, Wang X, Zhang P, Jin Y, Bai L, Wang W, Li Y, Liu J. Preoperative Iron Deficiency Is Associated With Increased Blood Transfusion in Infants Undergoing Cardiac Surgery. Front Cardiovasc Med. 2022 Jun 2;9:887535. doi: 10.3389/fcvm.2022.887535. eCollection 2022.

  PMID: 35722123 BACKGROUND

• Sidhu S, Kakkar S, Dewan P, Bansal N, Sobti PC. Adherence to Iron Chelation Therapy and Its Determinants. Int J Hematol Oncol Stem Cell Res. 2021 Jan 1;15(1):27-34. doi: 10.18502/ijhoscr.v15i1.5247.

  PMID: 33613898 BACKGROUND

• Temel HH, Kumbasar U, Buber E, Aksoy Y, Cavdar S, Dogan R, Demircin M, Pasaoglu I. Comparison of antioxidant reserve capacity of children with acyanotic & cyanotic congenital heart disease. Indian J Med Res. 2020 Dec;152(6):626-632. doi: 10.4103/ijmr.IJMR_2215_18.

  PMID: 34145102 BACKGROUND

• Christen S, Finckh B, Lykkesfeldt J, Gessler P, Frese-Schaper M, Nielsen P, Schmid ER, Schmitt B. Oxidative stress precedes peak systemic inflammatory response in pediatric patients undergoing cardiopulmonary bypass operation. Free Radic Biol Med. 2005 May 15;38(10):1323-32. doi: 10.1016/j.freeradbiomed.2005.01.016.

  PMID: 15855050 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Denis Schmartz, MD

CONTACT

+3225553919; denis.schmartz@hubruxelles.be

Ariane Willems, MD, PhD

CONTACT

+322477331; ariane.willems@hubruxelles.be

Study Design

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

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 26, 2024
• Study Start: February 23, 2024
• Primary Completion: April 20, 2024
• Study Completion: June 30, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)