Effects of ferric carboxymaltose on hemoglobin level after cardiac surgery: A randomized controlled trial.
Anemia
Cardiac surgery
Cardiopulmonary bypass
Postoperative intravenous iron
Transfusion rate
Journal
Anaesthesia, critical care & pain medicine
ISSN: 2352-5568
Titre abrégé: Anaesth Crit Care Pain Med
Pays: France
ID NLM: 101652401
Informations de publication
Date de publication:
02 2023
02 2023
Historique:
received:
19
04
2022
revised:
02
09
2022
accepted:
19
10
2022
pubmed:
15
11
2022
medline:
24
1
2023
entrez:
14
11
2022
Statut:
ppublish
Résumé
Perioperative anemia is common in cardiac surgery. Few studies investigated the effect of postoperative intravenous (IV) iron supplementation and were mostly inconclusive. Design: A randomized single-center, double-blind, placebo-controlled, parallel-group trial. 195 non-anemic patients were recruited from December 2018 to December 2020: 97 patients received 1 g of ferric carboxymaltose (FCM) and 98 patients received 100 mL of physiological serum on postoperative day 1. hemoglobin levels, reticulocyte count, serum iron, serum ferritin, and transferrin saturation were measured at induction of anesthesia, postoperative days 1, 5, and 30. Transfusion rate, duration of mechanical ventilation, critical care unit length of stay, and side effects associated with IV iron administration were measured. The primary outcome was hemoglobin level on day 30. Secondary outcomes included iron balance, transfused red cell packs, and critical care unit length of stay. At day 30, the hemoglobine level was higher in the FCM group than in the placebo group (mean 12.9 ± 1.2 vs. 12.1 ± 1.3 g/dL (95%CI 0.41-1.23, p-value <0.001)). Patients in the FCM group received fewer blood units (median 1[0-2] unit vs. 2 [0-3] units, p-value = 0.037) and had significant improvement in iron balance compared to the control group. No side effects associated with FCM administration were reported. In this randomized controlled trial, administration of FCM on postoperative day 1 in non-anemic patients undergoing cardiac surgery increased hemoglobin levels by 0.8 g/dL on postoperative day 30, leading to reduced transfusion rate, and improved iron levels on postoperative day 5 and 30. NCT03759964.
Sections du résumé
BACKGROUND
Perioperative anemia is common in cardiac surgery. Few studies investigated the effect of postoperative intravenous (IV) iron supplementation and were mostly inconclusive.
METHODS
Design: A randomized single-center, double-blind, placebo-controlled, parallel-group trial.
PARTICIPANTS
195 non-anemic patients were recruited from December 2018 to December 2020: 97 patients received 1 g of ferric carboxymaltose (FCM) and 98 patients received 100 mL of physiological serum on postoperative day 1.
MEASUREMENTS
hemoglobin levels, reticulocyte count, serum iron, serum ferritin, and transferrin saturation were measured at induction of anesthesia, postoperative days 1, 5, and 30. Transfusion rate, duration of mechanical ventilation, critical care unit length of stay, and side effects associated with IV iron administration were measured. The primary outcome was hemoglobin level on day 30. Secondary outcomes included iron balance, transfused red cell packs, and critical care unit length of stay.
RESULTS
At day 30, the hemoglobine level was higher in the FCM group than in the placebo group (mean 12.9 ± 1.2 vs. 12.1 ± 1.3 g/dL (95%CI 0.41-1.23, p-value <0.001)). Patients in the FCM group received fewer blood units (median 1[0-2] unit vs. 2 [0-3] units, p-value = 0.037) and had significant improvement in iron balance compared to the control group. No side effects associated with FCM administration were reported.
CONCLUSION
In this randomized controlled trial, administration of FCM on postoperative day 1 in non-anemic patients undergoing cardiac surgery increased hemoglobin levels by 0.8 g/dL on postoperative day 30, leading to reduced transfusion rate, and improved iron levels on postoperative day 5 and 30.
CLINICAL TRIAL REGISTRY NUMBER
NCT03759964.
Identifiants
pubmed: 36375780
pii: S2352-5568(22)00152-7
doi: 10.1016/j.accpm.2022.101171
pii:
doi:
Substances chimiques
ferric carboxymaltose
6897GXD6OE
Ferric Compounds
0
Iron
E1UOL152H7
Hemoglobins
0
Banques de données
ClinicalTrials.gov
['NCT03759964']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
101171Informations de copyright
Copyright © 2022 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.