Document Detail


The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial.
MedLine Citation:
PMID:  22940889     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: Anaemia is a frequent complication after cardiopulmonary bypass surgery. Iron therapy has been variably employed by medical centres over the years. In our study we test the clinical effectiveness of intravenous and oral iron supplementation in correcting anaemia, and its impact on blood transfusion requirements, in patients undergoing cardiopulmonary bypass surgery.
METHODS: A double-blind, randomized, placebo-controlled clinical trial with three parallel groups of patients. Group I (n = 54): intravenous iron(III)-hydroxide sucrose complex, three doses of 100 mg/24 h during pre- and postoperative hospitalization and 1 pill/24 h of oral placebo in the same period and during 1 month after discharge. Group II (n = 53): oral ferrous fumarate iron 1 pill/24 h pre- and postoperatively and during 1 month after discharge, and intravenous placebo while hospitalized. Group III (n = 52): oral and intravenous placebo pre- and postoperatively, following the same protocol. Data were collected preoperatively, at theatre, at intensive care unit admission, before hospital discharge and 1 month later.
RESULTS: (1) Baseline clinical and demographic characteristics and surgical procedures were similar in the three groups; (2) no inter-group differences were found in haemoglobin and haematocrit during the postoperative period; (3) the intravenous iron group showed higher serum ferritin levels at hospital discharge (1321 ± 495 ng/ml; P < 0.001) and 1 month later (610 ± 387; P < 0.001) compared with the other groups and (4) we did not observe statistical differences in blood transfusion requirements between the three groups.
CONCLUSIONS: The use of intravenous or oral iron supplementation proved ineffective in correcting anaemia after cardiopulmonary bypass and did not reduce blood transfusion requirements. [Current Controlled Trials number: NCT01078818 (oral and intravenous iron in patients postoperative cardiovascular surgery under EC)].
Authors:
Pilar Garrido-Martín; Mohamed Ibrahim Nassar-Mansur; Ramiro de la Llana-Ducrós; Tirso Ma Virgos-Aller; Patricia María Rodríguez Fortunez; Rosa Ávalos-Pinto; Alejandro Jimenez-Sosa; Rafael Martínez-Sanz
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial     Date:  2012-08-31
Journal Detail:
Title:  Interactive cardiovascular and thoracic surgery     Volume:  15     ISSN:  1569-9285     ISO Abbreviation:  Interact Cardiovasc Thorac Surg     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-20     Completed Date:  2013-05-06     Revised Date:  2013-12-05    
Medline Journal Info:
Nlm Unique ID:  101158399     Medline TA:  Interact Cardiovasc Thorac Surg     Country:  England    
Other Details:
Languages:  eng     Pagination:  1013-8     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01078818
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Aged
Analysis of Variance
Anemia, Iron-Deficiency / blood,  drug therapy*,  etiology
Blood Transfusion*
Cardiac Surgical Procedures / adverse effects*
Cardiopulmonary Bypass / adverse effects
Chi-Square Distribution
Double-Blind Method
Female
Ferric Compounds / administration & dosage*,  adverse effects
Ferrous Compounds / administration & dosage*,  adverse effects
Hematinics / administration & dosage*,  adverse effects
Humans
Infusions, Intravenous
Male
Middle Aged
Spain
Sucrose / administration & dosage*,  adverse effects
Surgical Procedures, Elective
Tablets
Time Factors
Treatment Failure
Chemical
Reg. No./Substance:
0/Ferric Compounds; 0/Ferrous Compounds; 0/Hematinics; 0/Tablets; 0/iron(III)-hydroxide sucrose complex; 57-50-1/Sucrose; R5L488RY0Q/ferrous fumarate
Comments/Corrections
Comment In:
Interact Cardiovasc Thorac Surg. 2012 Dec;15(6):1018; discussion 1018   [PMID:  23166216 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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