Efficacy of recombinant human erythropoietin in the critically ill patient: A randomized, double-blind, placebo-controlled trial
OBJECTIVE:To determine whether the administration of recombinant human erythropoietin (rHuEPO) to critically ill patients in the intensive care unit (ICU) would reduce the number of red blood cell (RBC) transfusions required. DESIGN:A prospective, randomized, double-blind, placebo-controlled, multic...
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| Veröffentlicht in: | Critical care medicine 1999-11, Vol.27 (11), p.2346-2350 |
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| creator | Corwin, Howard L Gettinger, Andrew Rodriguez, Robert M Pearl, Ronald G Gubler, K Dean Enny, Christopher Colton, Theodore Corwin, Michael J |
| description | OBJECTIVE:To determine whether the administration of recombinant human erythropoietin (rHuEPO) to critically ill patients in the intensive care unit (ICU) would reduce the number of red blood cell (RBC) transfusions required.
DESIGN:A prospective, randomized, double-blind, placebo-controlled, multicenter trial.
SETTING:ICUs at three academic tertiary care medical centers.
PATIENTS:A total of 160 patients who were admitted to the ICU and met the eligibility criteria were enrolled in the study (80 into the rHuEPO group; 80 into the placebo group).
INTERVENTIONS:Patients were randomized to receive either rHuEPO or placebo. The study drug (300 units/kg of rHuEPO or placebo) was administered by subcutaneous injection beginning ICU day 3 and continuing daily for a total of 5 days (until ICU day 7). The subsequent dosing schedule was every other day to achieve a hematocrit (Hct) concentration of >38%. The study drug was given for a minimum of 2 wks or until ICU discharge (for subjects with ICU lengths of stay >2 wks) up to a total of 6 wks (42 days) postrandomization.
MEASUREMENTS AND MAIN RESULTS:The cumulative number of units of RBCs transfused was significantly less in the rHuEPO group than in the placebo group (p < .002, Kolmogorov-Smirnov test). The rHuEPO group was transfused with a total of 166 units of RBCs vs. 305 units of RBCs transfused in the placebo group. The final Hct concentration of the rHuEPO patients was significantly greater than the final Hct concentration of placebo patients (35.1 ± 5.6 vs. 31.6 ± 4.1; p < .01, respectively). A total of 45% of patients in the rHuEPO group received a blood transfusion between days 8 and 42 or died before study day 42 compared with 55% of patients in the placebo group (relative risk, 0.8; 95% confidence interval, 0.6, 1.1). There were no significant differences between the two groups either in mortality or in the frequency of adverse events.
CONCLUSIONS:The administration of rHuEPO to critically ill patients is effective in raising their Hct concentrations and in reducing the total number of units of RBCs they require. |
| doi_str_mv | 10.1097/00003246-199911000-00004 |
| format | Article |
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DESIGN:A prospective, randomized, double-blind, placebo-controlled, multicenter trial.
SETTING:ICUs at three academic tertiary care medical centers.
PATIENTS:A total of 160 patients who were admitted to the ICU and met the eligibility criteria were enrolled in the study (80 into the rHuEPO group; 80 into the placebo group).
INTERVENTIONS:Patients were randomized to receive either rHuEPO or placebo. The study drug (300 units/kg of rHuEPO or placebo) was administered by subcutaneous injection beginning ICU day 3 and continuing daily for a total of 5 days (until ICU day 7). The subsequent dosing schedule was every other day to achieve a hematocrit (Hct) concentration of >38%. The study drug was given for a minimum of 2 wks or until ICU discharge (for subjects with ICU lengths of stay >2 wks) up to a total of 6 wks (42 days) postrandomization.
MEASUREMENTS AND MAIN RESULTS:The cumulative number of units of RBCs transfused was significantly less in the rHuEPO group than in the placebo group (p < .002, Kolmogorov-Smirnov test). The rHuEPO group was transfused with a total of 166 units of RBCs vs. 305 units of RBCs transfused in the placebo group. The final Hct concentration of the rHuEPO patients was significantly greater than the final Hct concentration of placebo patients (35.1 ± 5.6 vs. 31.6 ± 4.1; p < .01, respectively). A total of 45% of patients in the rHuEPO group received a blood transfusion between days 8 and 42 or died before study day 42 compared with 55% of patients in the placebo group (relative risk, 0.8; 95% confidence interval, 0.6, 1.1). There were no significant differences between the two groups either in mortality or in the frequency of adverse events.
CONCLUSIONS:The administration of rHuEPO to critically ill patients is effective in raising their Hct concentrations and in reducing the total number of units of RBCs they require.</description><identifier>ISSN: 0090-3493</identifier><identifier>EISSN: 1530-0293</identifier><identifier>DOI: 10.1097/00003246-199911000-00004</identifier><identifier>PMID: 10579246</identifier><identifier>CODEN: CCMDC7</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins, Inc</publisher><subject>Biological and medical sciences ; Blood. Blood coagulation. Reticuloendothelial system ; Critical Illness - mortality ; Critical Illness - therapy ; Double-Blind Method ; Erythrocyte Transfusion ; Erythropoietin - therapeutic use ; Female ; Hematocrit ; Humans ; Intensive Care Units ; Length of Stay ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Prospective Studies ; Recombinant Proteins ; Survival Rate ; Treatment Outcome</subject><ispartof>Critical care medicine, 1999-11, Vol.27 (11), p.2346-2350</ispartof><rights>1999 Lippincott Williams & Wilkins, Inc.</rights><rights>2000 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4514-d3b0d2aa9192920bb935d4b726ac3cf7b060461fdeebcea0a6f6fff692ebad0b3</citedby><cites>FETCH-LOGICAL-c4514-d3b0d2aa9192920bb935d4b726ac3cf7b060461fdeebcea0a6f6fff692ebad0b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,27933,27934</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1221585$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10579246$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Corwin, Howard L</creatorcontrib><creatorcontrib>Gettinger, Andrew</creatorcontrib><creatorcontrib>Rodriguez, Robert M</creatorcontrib><creatorcontrib>Pearl, Ronald G</creatorcontrib><creatorcontrib>Gubler, K Dean</creatorcontrib><creatorcontrib>Enny, Christopher</creatorcontrib><creatorcontrib>Colton, Theodore</creatorcontrib><creatorcontrib>Corwin, Michael J</creatorcontrib><title>Efficacy of recombinant human erythropoietin in the critically ill patient: A randomized, double-blind, placebo-controlled trial</title><title>Critical care medicine</title><addtitle>Crit Care Med</addtitle><description>OBJECTIVE:To determine whether the administration of recombinant human erythropoietin (rHuEPO) to critically ill patients in the intensive care unit (ICU) would reduce the number of red blood cell (RBC) transfusions required.
DESIGN:A prospective, randomized, double-blind, placebo-controlled, multicenter trial.
SETTING:ICUs at three academic tertiary care medical centers.
PATIENTS:A total of 160 patients who were admitted to the ICU and met the eligibility criteria were enrolled in the study (80 into the rHuEPO group; 80 into the placebo group).
INTERVENTIONS:Patients were randomized to receive either rHuEPO or placebo. The study drug (300 units/kg of rHuEPO or placebo) was administered by subcutaneous injection beginning ICU day 3 and continuing daily for a total of 5 days (until ICU day 7). The subsequent dosing schedule was every other day to achieve a hematocrit (Hct) concentration of >38%. The study drug was given for a minimum of 2 wks or until ICU discharge (for subjects with ICU lengths of stay >2 wks) up to a total of 6 wks (42 days) postrandomization.
MEASUREMENTS AND MAIN RESULTS:The cumulative number of units of RBCs transfused was significantly less in the rHuEPO group than in the placebo group (p < .002, Kolmogorov-Smirnov test). The rHuEPO group was transfused with a total of 166 units of RBCs vs. 305 units of RBCs transfused in the placebo group. The final Hct concentration of the rHuEPO patients was significantly greater than the final Hct concentration of placebo patients (35.1 ± 5.6 vs. 31.6 ± 4.1; p < .01, respectively). A total of 45% of patients in the rHuEPO group received a blood transfusion between days 8 and 42 or died before study day 42 compared with 55% of patients in the placebo group (relative risk, 0.8; 95% confidence interval, 0.6, 1.1). There were no significant differences between the two groups either in mortality or in the frequency of adverse events.
CONCLUSIONS:The administration of rHuEPO to critically ill patients is effective in raising their Hct concentrations and in reducing the total number of units of RBCs they require.</description><subject>Biological and medical sciences</subject><subject>Blood. Blood coagulation. Reticuloendothelial system</subject><subject>Critical Illness - mortality</subject><subject>Critical Illness - therapy</subject><subject>Double-Blind Method</subject><subject>Erythrocyte Transfusion</subject><subject>Erythropoietin - therapeutic use</subject><subject>Female</subject><subject>Hematocrit</subject><subject>Humans</subject><subject>Intensive Care Units</subject><subject>Length of Stay</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><subject>Recombinant Proteins</subject><subject>Survival Rate</subject><subject>Treatment Outcome</subject><issn>0090-3493</issn><issn>1530-0293</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUtrFTEYhoNY7LH6FyQLcdWxuc1M466UeoGCG10PuXxhoplkTDKU05U_vanneNkYAuH9eN4EniCEKXlLiRwvSFuciaGjUkpKW-oeR-IJ2tGet8Akf4p2hEjScSH5KXpeyjdCqOhH_gydUtKPsvV36OeNc94os8fJ4QwmLdpHFSuet0VFDHlf55zW5KH6iNuuM2CTfW2lEPbYh4BXVT3E-g5f4ayiTYu_B3uObdp0gE4HH1tagzKgU2dSrDmFABbX7FV4gU6cCgVeHs8z9PX9zZfrj93t5w-frq9uOyN6KjrLNbFMKUklk4xoLXlvhR7ZoAw3btRkIGKgzgJoA4qowQ3OuUEy0MoSzc_Qm8O9a04_Nih1WnwxEIKKkLYyDZKTnhHZwMsDaHIqJYOb1uwXlfcTJdOj_em3_emP_V8j0aqvjm9segH7T_GguwGvj4AqzZ9ruowvfznGaH_ZN0wcsLsUKuTyPWx3kKcZVKjz9L_P5w83rZ8i</recordid><startdate>199911</startdate><enddate>199911</enddate><creator>Corwin, Howard L</creator><creator>Gettinger, Andrew</creator><creator>Rodriguez, Robert M</creator><creator>Pearl, Ronald G</creator><creator>Gubler, K Dean</creator><creator>Enny, Christopher</creator><creator>Colton, Theodore</creator><creator>Corwin, Michael J</creator><general>Lippincott Williams & Wilkins, Inc</general><general>Lippincott</general><scope>IQODW</scope><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>7X8</scope></search><sort><creationdate>199911</creationdate><title>Efficacy of recombinant human erythropoietin in the critically ill patient: A randomized, double-blind, placebo-controlled trial</title><author>Corwin, Howard L ; Gettinger, Andrew ; Rodriguez, Robert M ; Pearl, Ronald G ; Gubler, K Dean ; Enny, Christopher ; Colton, Theodore ; Corwin, Michael J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4514-d3b0d2aa9192920bb935d4b726ac3cf7b060461fdeebcea0a6f6fff692ebad0b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>Biological and medical sciences</topic><topic>Blood. Blood coagulation. Reticuloendothelial system</topic><topic>Critical Illness - mortality</topic><topic>Critical Illness - therapy</topic><topic>Double-Blind Method</topic><topic>Erythrocyte Transfusion</topic><topic>Erythropoietin - therapeutic use</topic><topic>Female</topic><topic>Hematocrit</topic><topic>Humans</topic><topic>Intensive Care Units</topic><topic>Length of Stay</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Prospective Studies</topic><topic>Recombinant Proteins</topic><topic>Survival Rate</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Corwin, Howard L</creatorcontrib><creatorcontrib>Gettinger, Andrew</creatorcontrib><creatorcontrib>Rodriguez, Robert M</creatorcontrib><creatorcontrib>Pearl, Ronald G</creatorcontrib><creatorcontrib>Gubler, K Dean</creatorcontrib><creatorcontrib>Enny, Christopher</creatorcontrib><creatorcontrib>Colton, Theodore</creatorcontrib><creatorcontrib>Corwin, Michael J</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Critical care medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Corwin, Howard L</au><au>Gettinger, Andrew</au><au>Rodriguez, Robert M</au><au>Pearl, Ronald G</au><au>Gubler, K Dean</au><au>Enny, Christopher</au><au>Colton, Theodore</au><au>Corwin, Michael J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of recombinant human erythropoietin in the critically ill patient: A randomized, double-blind, placebo-controlled trial</atitle><jtitle>Critical care medicine</jtitle><addtitle>Crit Care Med</addtitle><date>1999-11</date><risdate>1999</risdate><volume>27</volume><issue>11</issue><spage>2346</spage><epage>2350</epage><pages>2346-2350</pages><issn>0090-3493</issn><eissn>1530-0293</eissn><coden>CCMDC7</coden><abstract>OBJECTIVE:To determine whether the administration of recombinant human erythropoietin (rHuEPO) to critically ill patients in the intensive care unit (ICU) would reduce the number of red blood cell (RBC) transfusions required.
DESIGN:A prospective, randomized, double-blind, placebo-controlled, multicenter trial.
SETTING:ICUs at three academic tertiary care medical centers.
PATIENTS:A total of 160 patients who were admitted to the ICU and met the eligibility criteria were enrolled in the study (80 into the rHuEPO group; 80 into the placebo group).
INTERVENTIONS:Patients were randomized to receive either rHuEPO or placebo. The study drug (300 units/kg of rHuEPO or placebo) was administered by subcutaneous injection beginning ICU day 3 and continuing daily for a total of 5 days (until ICU day 7). The subsequent dosing schedule was every other day to achieve a hematocrit (Hct) concentration of >38%. The study drug was given for a minimum of 2 wks or until ICU discharge (for subjects with ICU lengths of stay >2 wks) up to a total of 6 wks (42 days) postrandomization.
MEASUREMENTS AND MAIN RESULTS:The cumulative number of units of RBCs transfused was significantly less in the rHuEPO group than in the placebo group (p < .002, Kolmogorov-Smirnov test). The rHuEPO group was transfused with a total of 166 units of RBCs vs. 305 units of RBCs transfused in the placebo group. The final Hct concentration of the rHuEPO patients was significantly greater than the final Hct concentration of placebo patients (35.1 ± 5.6 vs. 31.6 ± 4.1; p < .01, respectively). A total of 45% of patients in the rHuEPO group received a blood transfusion between days 8 and 42 or died before study day 42 compared with 55% of patients in the placebo group (relative risk, 0.8; 95% confidence interval, 0.6, 1.1). There were no significant differences between the two groups either in mortality or in the frequency of adverse events.
CONCLUSIONS:The administration of rHuEPO to critically ill patients is effective in raising their Hct concentrations and in reducing the total number of units of RBCs they require.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>10579246</pmid><doi>10.1097/00003246-199911000-00004</doi><tpages>5</tpages></addata></record> |
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| identifier | ISSN: 0090-3493 |
| ispartof | Critical care medicine, 1999-11, Vol.27 (11), p.2346-2350 |
| issn | 0090-3493 1530-0293 |
| language | eng |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Biological and medical sciences Blood. Blood coagulation. Reticuloendothelial system Critical Illness - mortality Critical Illness - therapy Double-Blind Method Erythrocyte Transfusion Erythropoietin - therapeutic use Female Hematocrit Humans Intensive Care Units Length of Stay Male Medical sciences Middle Aged Pharmacology. Drug treatments Prospective Studies Recombinant Proteins Survival Rate Treatment Outcome |
| title | Efficacy of recombinant human erythropoietin in the critically ill patient: A randomized, double-blind, placebo-controlled trial |
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