A prospective comparison of three argatroban treatment regimens during hemodialysis in end-stage renal disease
A prospective comparison of three argatroban treatment regimens during hemodialysis in end-stage renal disease. We prospectively evaluated 3 treatment regimens of argatroban, a direct thrombin inhibitor, for providing adequate, safe anticoagulation in patients with end-stage renal disease (ESRD) dur...
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| Veröffentlicht in: | Kidney international 2004-12, Vol.66 (6), p.2446-2453 |
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| creator | Murray, Patrick T. Reddy, Bharathi V. Grossman, Eric J. Hammes, Mary S. Trevino, Sharon Ferrell, Janice Tang, Ignatius Hursting, Marcie J. Shamp, Trisha R. Swan, Suzanne K. |
| description | A prospective comparison of three argatroban treatment regimens during hemodialysis in end-stage renal disease.
We prospectively evaluated 3 treatment regimens of argatroban, a direct thrombin inhibitor, for providing adequate, safe anticoagulation in patients with end-stage renal disease (ESRD) during hemodialysis.
In this randomized, 3-way crossover study, ESRD patients underwent hemodialysis sessions of 3- or 4-hour duration using high-flux membranes and each of 3 argatroban treatment regimens (A: 250-μg/kg bolus, with an additional 250-μg/kg bolus allowed; B: 250-μg/kg bolus followed by 2-μg/kg/min infusion; C: steady-state, 2-μg/kg/min infusion initiated 4 hours before dialysis). Pharmacodynamic effects including activated clotting times (ACTs); hemodialysis efficacy including single-pool Kt/V, urea reduction ratio (URR), and circuit flow; and safety through a 3-day follow-up were monitored. Argatroban pharmacokinetic parameters including dialytic clearance were evaluated during regimen C.
Thirteen patients completed 38 hemodialysis sessions (1 patient withdrew consent after 2 sessions). Mean ± SD ACTs increased from 131 ± 14 seconds at baseline to 153 ± 24, 200 ± 30, and 197 ± 33 seconds, respectively, after 60 minutes of hemodialysis using regimens A, B, and C. Across regimens, mean Kt/Vs (1.5–1.6) and URRs (70%-73%) were comparable. No dialyzer was changed; 1 session was shortened 15 minutes because of circuit clot formation. Systemic argatroban clearance increased ∼20% during hemodialysis, without clinically significantly affecting ACTs. Upon argatroban discontinuation, ACTs and plasma argatroban decreased concurrently (elimination half-life, 35 ± 6 min). No thrombosis, bleeding, serious adverse events, or clinically significant changes in vital signs or routine laboratory measures occurred.
Argatroban, administered by each treatment regimen, provides safe, adequate anticoagulation to enable successful hemodialysis in ESRD patients. Argatroban dialytic clearance by high-flux membranes is clinically insignificant. |
| doi_str_mv | 10.1111/j.1523-1755.2004.66022.x |
| format | Article |
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We prospectively evaluated 3 treatment regimens of argatroban, a direct thrombin inhibitor, for providing adequate, safe anticoagulation in patients with end-stage renal disease (ESRD) during hemodialysis.
In this randomized, 3-way crossover study, ESRD patients underwent hemodialysis sessions of 3- or 4-hour duration using high-flux membranes and each of 3 argatroban treatment regimens (A: 250-μg/kg bolus, with an additional 250-μg/kg bolus allowed; B: 250-μg/kg bolus followed by 2-μg/kg/min infusion; C: steady-state, 2-μg/kg/min infusion initiated 4 hours before dialysis). Pharmacodynamic effects including activated clotting times (ACTs); hemodialysis efficacy including single-pool Kt/V, urea reduction ratio (URR), and circuit flow; and safety through a 3-day follow-up were monitored. Argatroban pharmacokinetic parameters including dialytic clearance were evaluated during regimen C.
Thirteen patients completed 38 hemodialysis sessions (1 patient withdrew consent after 2 sessions). Mean ± SD ACTs increased from 131 ± 14 seconds at baseline to 153 ± 24, 200 ± 30, and 197 ± 33 seconds, respectively, after 60 minutes of hemodialysis using regimens A, B, and C. Across regimens, mean Kt/Vs (1.5–1.6) and URRs (70%-73%) were comparable. No dialyzer was changed; 1 session was shortened 15 minutes because of circuit clot formation. Systemic argatroban clearance increased ∼20% during hemodialysis, without clinically significantly affecting ACTs. Upon argatroban discontinuation, ACTs and plasma argatroban decreased concurrently (elimination half-life, 35 ± 6 min). No thrombosis, bleeding, serious adverse events, or clinically significant changes in vital signs or routine laboratory measures occurred.
Argatroban, administered by each treatment regimen, provides safe, adequate anticoagulation to enable successful hemodialysis in ESRD patients. Argatroban dialytic clearance by high-flux membranes is clinically insignificant.</description><identifier>ISSN: 0085-2538</identifier><identifier>EISSN: 1523-1755</identifier><identifier>DOI: 10.1111/j.1523-1755.2004.66022.x</identifier><identifier>PMID: 15569338</identifier><identifier>CODEN: KDYIA5</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adult ; Aged ; Anticoagulants - administration & dosage ; Anticoagulants - adverse effects ; Anticoagulants - pharmacokinetics ; anticoagulation ; argatroban ; Biological and medical sciences ; Cross-Over Studies ; end-stage renal disease ; Female ; hemodialysis ; Humans ; Kidney Failure, Chronic - therapy ; Male ; Medical sciences ; Middle Aged ; Nephrology. Urinary tract diseases ; Nephropathies. Renovascular diseases. Renal failure ; Pipecolic Acids - administration & dosage ; Pipecolic Acids - adverse effects ; Pipecolic Acids - pharmacokinetics ; Prospective Studies ; Renal Dialysis - methods ; Renal Dialysis - standards ; Renal failure ; Thrombosis - drug therapy ; Thrombosis - prevention & control</subject><ispartof>Kidney international, 2004-12, Vol.66 (6), p.2446-2453</ispartof><rights>2004 International Society of Nephrology</rights><rights>2005 INIST-CNRS</rights><rights>Copyright Nature Publishing Group Dec 2004</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c479t-7177fa46521098c58634170952622b732c1a91f36c0492ed8d3ecd001641a6de3</citedby><cites>FETCH-LOGICAL-c479t-7177fa46521098c58634170952622b732c1a91f36c0492ed8d3ecd001641a6de3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16330812$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15569338$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Murray, Patrick T.</creatorcontrib><creatorcontrib>Reddy, Bharathi V.</creatorcontrib><creatorcontrib>Grossman, Eric J.</creatorcontrib><creatorcontrib>Hammes, Mary S.</creatorcontrib><creatorcontrib>Trevino, Sharon</creatorcontrib><creatorcontrib>Ferrell, Janice</creatorcontrib><creatorcontrib>Tang, Ignatius</creatorcontrib><creatorcontrib>Hursting, Marcie J.</creatorcontrib><creatorcontrib>Shamp, Trisha R.</creatorcontrib><creatorcontrib>Swan, Suzanne K.</creatorcontrib><title>A prospective comparison of three argatroban treatment regimens during hemodialysis in end-stage renal disease</title><title>Kidney international</title><addtitle>Kidney Int</addtitle><description>A prospective comparison of three argatroban treatment regimens during hemodialysis in end-stage renal disease.
We prospectively evaluated 3 treatment regimens of argatroban, a direct thrombin inhibitor, for providing adequate, safe anticoagulation in patients with end-stage renal disease (ESRD) during hemodialysis.
In this randomized, 3-way crossover study, ESRD patients underwent hemodialysis sessions of 3- or 4-hour duration using high-flux membranes and each of 3 argatroban treatment regimens (A: 250-μg/kg bolus, with an additional 250-μg/kg bolus allowed; B: 250-μg/kg bolus followed by 2-μg/kg/min infusion; C: steady-state, 2-μg/kg/min infusion initiated 4 hours before dialysis). Pharmacodynamic effects including activated clotting times (ACTs); hemodialysis efficacy including single-pool Kt/V, urea reduction ratio (URR), and circuit flow; and safety through a 3-day follow-up were monitored. Argatroban pharmacokinetic parameters including dialytic clearance were evaluated during regimen C.
Thirteen patients completed 38 hemodialysis sessions (1 patient withdrew consent after 2 sessions). Mean ± SD ACTs increased from 131 ± 14 seconds at baseline to 153 ± 24, 200 ± 30, and 197 ± 33 seconds, respectively, after 60 minutes of hemodialysis using regimens A, B, and C. Across regimens, mean Kt/Vs (1.5–1.6) and URRs (70%-73%) were comparable. No dialyzer was changed; 1 session was shortened 15 minutes because of circuit clot formation. Systemic argatroban clearance increased ∼20% during hemodialysis, without clinically significantly affecting ACTs. Upon argatroban discontinuation, ACTs and plasma argatroban decreased concurrently (elimination half-life, 35 ± 6 min). No thrombosis, bleeding, serious adverse events, or clinically significant changes in vital signs or routine laboratory measures occurred.
Argatroban, administered by each treatment regimen, provides safe, adequate anticoagulation to enable successful hemodialysis in ESRD patients. Argatroban dialytic clearance by high-flux membranes is clinically insignificant.</description><subject>Adult</subject><subject>Aged</subject><subject>Anticoagulants - administration & dosage</subject><subject>Anticoagulants - adverse effects</subject><subject>Anticoagulants - pharmacokinetics</subject><subject>anticoagulation</subject><subject>argatroban</subject><subject>Biological and medical sciences</subject><subject>Cross-Over Studies</subject><subject>end-stage renal disease</subject><subject>Female</subject><subject>hemodialysis</subject><subject>Humans</subject><subject>Kidney Failure, Chronic - therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Nephropathies. Renovascular diseases. Renal failure</subject><subject>Pipecolic Acids - administration & dosage</subject><subject>Pipecolic Acids - adverse effects</subject><subject>Pipecolic Acids - pharmacokinetics</subject><subject>Prospective Studies</subject><subject>Renal Dialysis - methods</subject><subject>Renal Dialysis - standards</subject><subject>Renal failure</subject><subject>Thrombosis - drug therapy</subject><subject>Thrombosis - prevention & control</subject><issn>0085-2538</issn><issn>1523-1755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqFkU1v3CAQhlGVqNlu-xcqFKlHu3wYbB_TKB-VIuWSnBEL4w2rNd4wbJT8--LuKjmGC4x45tXwQAjlrOZl_d7UXAlZ8VapWjDW1FozIerXL2TxfnFCFox1qhJKdmfkG-KGlbqX7Cs540rpXspuQeIF3aUJd-ByeAHqpnFnU8Ap0mmg-SkBUJvWNqdpZSPNCWweIWaaYB3KAanfpxDX9AnGyQe7fcOANEQK0VeY7RoKGe2W-oBgEb6T08FuEX4c9yV5vL56uLyt7u5v_l5e3FWuaftctbxtB9toJTjrO6c6LRvesl4JLcSqlcJx2_NBaseaXoDvvATnGeO64VZ7kEtyfsgtj3veA2azmfapDIKmRM6hRdOSdAfIFQOYYDC7FEab3gxnZvZsNmbWaWadZvZs_ns2r6X15zF_vxrBfzQexRbg1xGw6Ox2SDa6gB-clpJ1fJ7hz4GDYuMlQDLoAkQHPqTyJ8ZP4fNp_gGSqZwI</recordid><startdate>20041201</startdate><enddate>20041201</enddate><creator>Murray, Patrick T.</creator><creator>Reddy, Bharathi V.</creator><creator>Grossman, Eric J.</creator><creator>Hammes, Mary S.</creator><creator>Trevino, Sharon</creator><creator>Ferrell, Janice</creator><creator>Tang, Ignatius</creator><creator>Hursting, Marcie J.</creator><creator>Shamp, Trisha R.</creator><creator>Swan, Suzanne K.</creator><general>Elsevier Inc</general><general>Nature Publishing</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><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>3V.</scope><scope>7QP</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20041201</creationdate><title>A prospective comparison of three argatroban treatment regimens during hemodialysis in end-stage renal disease</title><author>Murray, Patrick T. ; Reddy, Bharathi V. ; Grossman, Eric J. ; Hammes, Mary S. ; Trevino, Sharon ; Ferrell, Janice ; Tang, Ignatius ; Hursting, Marcie J. ; Shamp, Trisha R. ; Swan, Suzanne K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c479t-7177fa46521098c58634170952622b732c1a91f36c0492ed8d3ecd001641a6de3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anticoagulants - administration & dosage</topic><topic>Anticoagulants - adverse effects</topic><topic>Anticoagulants - pharmacokinetics</topic><topic>anticoagulation</topic><topic>argatroban</topic><topic>Biological and medical sciences</topic><topic>Cross-Over Studies</topic><topic>end-stage renal disease</topic><topic>Female</topic><topic>hemodialysis</topic><topic>Humans</topic><topic>Kidney Failure, Chronic - therapy</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Nephropathies. Renovascular diseases. Renal failure</topic><topic>Pipecolic Acids - administration & dosage</topic><topic>Pipecolic Acids - adverse effects</topic><topic>Pipecolic Acids - pharmacokinetics</topic><topic>Prospective Studies</topic><topic>Renal Dialysis - methods</topic><topic>Renal Dialysis - standards</topic><topic>Renal failure</topic><topic>Thrombosis - drug therapy</topic><topic>Thrombosis - prevention & control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Murray, Patrick T.</creatorcontrib><creatorcontrib>Reddy, Bharathi V.</creatorcontrib><creatorcontrib>Grossman, Eric J.</creatorcontrib><creatorcontrib>Hammes, Mary S.</creatorcontrib><creatorcontrib>Trevino, Sharon</creatorcontrib><creatorcontrib>Ferrell, Janice</creatorcontrib><creatorcontrib>Tang, Ignatius</creatorcontrib><creatorcontrib>Hursting, Marcie J.</creatorcontrib><creatorcontrib>Shamp, Trisha R.</creatorcontrib><creatorcontrib>Swan, Suzanne K.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><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>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Kidney international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Murray, Patrick T.</au><au>Reddy, Bharathi V.</au><au>Grossman, Eric J.</au><au>Hammes, Mary S.</au><au>Trevino, Sharon</au><au>Ferrell, Janice</au><au>Tang, Ignatius</au><au>Hursting, Marcie J.</au><au>Shamp, Trisha R.</au><au>Swan, Suzanne K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A prospective comparison of three argatroban treatment regimens during hemodialysis in end-stage renal disease</atitle><jtitle>Kidney international</jtitle><addtitle>Kidney Int</addtitle><date>2004-12-01</date><risdate>2004</risdate><volume>66</volume><issue>6</issue><spage>2446</spage><epage>2453</epage><pages>2446-2453</pages><issn>0085-2538</issn><eissn>1523-1755</eissn><coden>KDYIA5</coden><abstract>A prospective comparison of three argatroban treatment regimens during hemodialysis in end-stage renal disease.
We prospectively evaluated 3 treatment regimens of argatroban, a direct thrombin inhibitor, for providing adequate, safe anticoagulation in patients with end-stage renal disease (ESRD) during hemodialysis.
In this randomized, 3-way crossover study, ESRD patients underwent hemodialysis sessions of 3- or 4-hour duration using high-flux membranes and each of 3 argatroban treatment regimens (A: 250-μg/kg bolus, with an additional 250-μg/kg bolus allowed; B: 250-μg/kg bolus followed by 2-μg/kg/min infusion; C: steady-state, 2-μg/kg/min infusion initiated 4 hours before dialysis). Pharmacodynamic effects including activated clotting times (ACTs); hemodialysis efficacy including single-pool Kt/V, urea reduction ratio (URR), and circuit flow; and safety through a 3-day follow-up were monitored. Argatroban pharmacokinetic parameters including dialytic clearance were evaluated during regimen C.
Thirteen patients completed 38 hemodialysis sessions (1 patient withdrew consent after 2 sessions). Mean ± SD ACTs increased from 131 ± 14 seconds at baseline to 153 ± 24, 200 ± 30, and 197 ± 33 seconds, respectively, after 60 minutes of hemodialysis using regimens A, B, and C. Across regimens, mean Kt/Vs (1.5–1.6) and URRs (70%-73%) were comparable. No dialyzer was changed; 1 session was shortened 15 minutes because of circuit clot formation. Systemic argatroban clearance increased ∼20% during hemodialysis, without clinically significantly affecting ACTs. Upon argatroban discontinuation, ACTs and plasma argatroban decreased concurrently (elimination half-life, 35 ± 6 min). No thrombosis, bleeding, serious adverse events, or clinically significant changes in vital signs or routine laboratory measures occurred.
Argatroban, administered by each treatment regimen, provides safe, adequate anticoagulation to enable successful hemodialysis in ESRD patients. Argatroban dialytic clearance by high-flux membranes is clinically insignificant.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>15569338</pmid><doi>10.1111/j.1523-1755.2004.66022.x</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Anticoagulants - administration & dosage Anticoagulants - adverse effects Anticoagulants - pharmacokinetics anticoagulation argatroban Biological and medical sciences Cross-Over Studies end-stage renal disease Female hemodialysis Humans Kidney Failure, Chronic - therapy Male Medical sciences Middle Aged Nephrology. Urinary tract diseases Nephropathies. Renovascular diseases. Renal failure Pipecolic Acids - administration & dosage Pipecolic Acids - adverse effects Pipecolic Acids - pharmacokinetics Prospective Studies Renal Dialysis - methods Renal Dialysis - standards Renal failure Thrombosis - drug therapy Thrombosis - prevention & control |
| title | A prospective comparison of three argatroban treatment regimens during hemodialysis in end-stage renal disease |
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