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The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial
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 o test the clinical effectiveness of intravenous and oral iron supplementation in correcting anaemia, and its impact on...
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| Published in: | Interactive cardiovascular and thoracic surgery 2012-12, Vol.15 (6), p.1013-1018 |
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| creator | Garrido-Martín, Pilar Nassar-Mansur, Mohamed Ibrahim de la Llana-Ducrós, Ramiro Virgos-Aller, Tirso Mª Fortunez, Patricia María Rodríguez Ávalos-Pinto, Rosa Jimenez-Sosa, Alejandro Martínez-Sanz, Rafael |
| description | 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 o 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)]. |
| doi_str_mv | 10.1093/icvts/ivs344 |
| format | article |
| fullrecord | <record><control><sourceid>oup_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3501294</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/icvts/ivs344</oup_id><sourcerecordid>10.1093/icvts/ivs344</sourcerecordid><originalsourceid>FETCH-LOGICAL-c416t-1ab0d2126fd104069c3b7679bcaba52e73c49aadb5600f4fff438b50995a297c3</originalsourceid><addsrcrecordid>eNp9kU1r3DAQhkVoab56y7no1ks3kSzbu-qhUEKTFAK9JGczlkYbFVtyJduQ_LP-u8zuJktzKQhppHnmHTEvY2dSnEuh1YU385gv_JxVWR6wI1nVeqGLVfVuH2t1yI5z_i2E1EKJD-ywKHQpVit9xP7ePSBH59CMPDruw5hgxhCnzCFYHhN03KcYONjeB58pPXq60how-UgbPcxINGDvYVtFUMhuyhsw4Z_JJ-wxjJnk-UD4Np6CxbSOPqw5dtR-I2IgWQ-G5ymtMT1-5cBJysbeP6HlpqMfGPrQmDx0p-y9gy7jx5fzhN1f_bi7vFnc_rr-efn9dmFKWY8LCa2whSxqZ6UoRa2Napf1UrcGWqgKXCpTagDbVrUQrnTOlWrVVkLrCgq9NOqEfdvpDlPbozW4GVHXDMn3kB6bCL55mwn-oVnHuVGVkDRnEviyEzAp5pzQ7WulaDYWNlsLm52FhH_6t98efvWMgM87IE7D_6WeAfB-r1Y</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial</title><source>PubMed Central</source><creator>Garrido-Martín, Pilar ; Nassar-Mansur, Mohamed Ibrahim ; de la Llana-Ducrós, Ramiro ; Virgos-Aller, Tirso Mª ; Fortunez, Patricia María Rodríguez ; Ávalos-Pinto, Rosa ; Jimenez-Sosa, Alejandro ; Martínez-Sanz, Rafael</creator><creatorcontrib>Garrido-Martín, Pilar ; Nassar-Mansur, Mohamed Ibrahim ; de la Llana-Ducrós, Ramiro ; Virgos-Aller, Tirso Mª ; Fortunez, Patricia María Rodríguez ; Ávalos-Pinto, Rosa ; Jimenez-Sosa, Alejandro ; Martínez-Sanz, Rafael</creatorcontrib><description>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 o 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)].</description><identifier>ISSN: 1569-9293</identifier><identifier>EISSN: 1569-9285</identifier><identifier>DOI: 10.1093/icvts/ivs344</identifier><identifier>PMID: 22940889</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Administration, Oral ; Aged ; Analysis of Variance ; Anemia, Iron-Deficiency - blood ; Anemia, Iron-Deficiency - drug therapy ; Anemia, Iron-Deficiency - etiology ; Blood Transfusion ; Cardiac Surgical Procedures - adverse effects ; Cardiopulmonary Bypass - adverse effects ; Chi-Square Distribution ; Double-Blind Method ; Elective Surgical Procedures ; Female ; Ferric Compounds - administration & dosage ; Ferric Compounds - adverse effects ; Ferrous Compounds - administration & dosage ; Ferrous Compounds - adverse effects ; Glucaric Acid ; Hematinics - administration & dosage ; Hematinics - adverse effects ; Humans ; Infusions, Intravenous ; Male ; Middle Aged ; Original ; Spain ; Sucrose - administration & dosage ; Sucrose - adverse effects ; Tablets ; Time Factors ; Treatment Failure</subject><ispartof>Interactive cardiovascular and thoracic surgery, 2012-12, Vol.15 (6), p.1013-1018</ispartof><rights>The Author 2012. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c416t-1ab0d2126fd104069c3b7679bcaba52e73c49aadb5600f4fff438b50995a297c3</citedby><cites>FETCH-LOGICAL-c416t-1ab0d2126fd104069c3b7679bcaba52e73c49aadb5600f4fff438b50995a297c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3501294/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3501294/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,315,733,786,790,891,27957,27958,53827,53829</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22940889$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Garrido-Martín, Pilar</creatorcontrib><creatorcontrib>Nassar-Mansur, Mohamed Ibrahim</creatorcontrib><creatorcontrib>de la Llana-Ducrós, Ramiro</creatorcontrib><creatorcontrib>Virgos-Aller, Tirso Mª</creatorcontrib><creatorcontrib>Fortunez, Patricia María Rodríguez</creatorcontrib><creatorcontrib>Ávalos-Pinto, Rosa</creatorcontrib><creatorcontrib>Jimenez-Sosa, Alejandro</creatorcontrib><creatorcontrib>Martínez-Sanz, Rafael</creatorcontrib><title>The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial</title><title>Interactive cardiovascular and thoracic surgery</title><addtitle>Interact Cardiovasc Thorac Surg</addtitle><description>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 o 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)].</description><subject>Administration, Oral</subject><subject>Aged</subject><subject>Analysis of Variance</subject><subject>Anemia, Iron-Deficiency - blood</subject><subject>Anemia, Iron-Deficiency - drug therapy</subject><subject>Anemia, Iron-Deficiency - etiology</subject><subject>Blood Transfusion</subject><subject>Cardiac Surgical Procedures - adverse effects</subject><subject>Cardiopulmonary Bypass - adverse effects</subject><subject>Chi-Square Distribution</subject><subject>Double-Blind Method</subject><subject>Elective Surgical Procedures</subject><subject>Female</subject><subject>Ferric Compounds - administration & dosage</subject><subject>Ferric Compounds - adverse effects</subject><subject>Ferrous Compounds - administration & dosage</subject><subject>Ferrous Compounds - adverse effects</subject><subject>Glucaric Acid</subject><subject>Hematinics - administration & dosage</subject><subject>Hematinics - adverse effects</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Spain</subject><subject>Sucrose - administration & dosage</subject><subject>Sucrose - adverse effects</subject><subject>Tablets</subject><subject>Time Factors</subject><subject>Treatment Failure</subject><issn>1569-9293</issn><issn>1569-9285</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><recordid>eNp9kU1r3DAQhkVoab56y7no1ks3kSzbu-qhUEKTFAK9JGczlkYbFVtyJduQ_LP-u8zuJktzKQhppHnmHTEvY2dSnEuh1YU385gv_JxVWR6wI1nVeqGLVfVuH2t1yI5z_i2E1EKJD-ywKHQpVit9xP7ePSBH59CMPDruw5hgxhCnzCFYHhN03KcYONjeB58pPXq60how-UgbPcxINGDvYVtFUMhuyhsw4Z_JJ-wxjJnk-UD4Np6CxbSOPqw5dtR-I2IgWQ-G5ymtMT1-5cBJysbeP6HlpqMfGPrQmDx0p-y9gy7jx5fzhN1f_bi7vFnc_rr-efn9dmFKWY8LCa2whSxqZ6UoRa2Napf1UrcGWqgKXCpTagDbVrUQrnTOlWrVVkLrCgq9NOqEfdvpDlPbozW4GVHXDMn3kB6bCL55mwn-oVnHuVGVkDRnEviyEzAp5pzQ7WulaDYWNlsLm52FhH_6t98efvWMgM87IE7D_6WeAfB-r1Y</recordid><startdate>20121201</startdate><enddate>20121201</enddate><creator>Garrido-Martín, Pilar</creator><creator>Nassar-Mansur, Mohamed Ibrahim</creator><creator>de la Llana-Ducrós, Ramiro</creator><creator>Virgos-Aller, Tirso Mª</creator><creator>Fortunez, Patricia María Rodríguez</creator><creator>Ávalos-Pinto, Rosa</creator><creator>Jimenez-Sosa, Alejandro</creator><creator>Martínez-Sanz, Rafael</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20121201</creationdate><title>The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial</title><author>Garrido-Martín, Pilar ; Nassar-Mansur, Mohamed Ibrahim ; de la Llana-Ducrós, Ramiro ; Virgos-Aller, Tirso Mª ; Fortunez, Patricia María Rodríguez ; Ávalos-Pinto, Rosa ; Jimenez-Sosa, Alejandro ; Martínez-Sanz, Rafael</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c416t-1ab0d2126fd104069c3b7679bcaba52e73c49aadb5600f4fff438b50995a297c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Administration, Oral</topic><topic>Aged</topic><topic>Analysis of Variance</topic><topic>Anemia, Iron-Deficiency - blood</topic><topic>Anemia, Iron-Deficiency - drug therapy</topic><topic>Anemia, Iron-Deficiency - etiology</topic><topic>Blood Transfusion</topic><topic>Cardiac Surgical Procedures - adverse effects</topic><topic>Cardiopulmonary Bypass - adverse effects</topic><topic>Chi-Square Distribution</topic><topic>Double-Blind Method</topic><topic>Elective Surgical Procedures</topic><topic>Female</topic><topic>Ferric Compounds - administration & dosage</topic><topic>Ferric Compounds - adverse effects</topic><topic>Ferrous Compounds - administration & dosage</topic><topic>Ferrous Compounds - adverse effects</topic><topic>Glucaric Acid</topic><topic>Hematinics - administration & dosage</topic><topic>Hematinics - adverse effects</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Spain</topic><topic>Sucrose - administration & dosage</topic><topic>Sucrose - adverse effects</topic><topic>Tablets</topic><topic>Time Factors</topic><topic>Treatment Failure</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Garrido-Martín, Pilar</creatorcontrib><creatorcontrib>Nassar-Mansur, Mohamed Ibrahim</creatorcontrib><creatorcontrib>de la Llana-Ducrós, Ramiro</creatorcontrib><creatorcontrib>Virgos-Aller, Tirso Mª</creatorcontrib><creatorcontrib>Fortunez, Patricia María Rodríguez</creatorcontrib><creatorcontrib>Ávalos-Pinto, Rosa</creatorcontrib><creatorcontrib>Jimenez-Sosa, Alejandro</creatorcontrib><creatorcontrib>Martínez-Sanz, Rafael</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Interactive cardiovascular and thoracic surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Garrido-Martín, Pilar</au><au>Nassar-Mansur, Mohamed Ibrahim</au><au>de la Llana-Ducrós, Ramiro</au><au>Virgos-Aller, Tirso Mª</au><au>Fortunez, Patricia María Rodríguez</au><au>Ávalos-Pinto, Rosa</au><au>Jimenez-Sosa, Alejandro</au><au>Martínez-Sanz, Rafael</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial</atitle><jtitle>Interactive cardiovascular and thoracic surgery</jtitle><addtitle>Interact Cardiovasc Thorac Surg</addtitle><date>2012-12-01</date><risdate>2012</risdate><volume>15</volume><issue>6</issue><spage>1013</spage><epage>1018</epage><pages>1013-1018</pages><issn>1569-9293</issn><eissn>1569-9285</eissn><abstract>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 o 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)].</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>22940889</pmid><doi>10.1093/icvts/ivs344</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Interactive cardiovascular and thoracic surgery, 2012-12, Vol.15 (6), p.1013-1018 |
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| source | PubMed Central |
| subjects | Administration, Oral Aged Analysis of Variance Anemia, Iron-Deficiency - blood Anemia, Iron-Deficiency - drug therapy Anemia, Iron-Deficiency - etiology Blood Transfusion Cardiac Surgical Procedures - adverse effects Cardiopulmonary Bypass - adverse effects Chi-Square Distribution Double-Blind Method Elective Surgical Procedures Female Ferric Compounds - administration & dosage Ferric Compounds - adverse effects Ferrous Compounds - administration & dosage Ferrous Compounds - adverse effects Glucaric Acid Hematinics - administration & dosage Hematinics - adverse effects Humans Infusions, Intravenous Male Middle Aged Original Spain Sucrose - administration & dosage Sucrose - adverse effects Tablets Time Factors Treatment Failure |
| title | The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial |
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