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Originals

Efficacy and safety of intermittent hemodialysis using citrate as anticoagulant: a prospective study

M. Schneider, K. Thomas, L. Liefeldt, D. Kindgen-Milles, H. Peters, H.-H. Neumayer and S. Morgera

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Volume 68 (2007) p. 302 - 307

Abstract

M. Schneider, K. Thomas, L. Liefeldt, D. Kindgen-Milles, H. Peters, H.-H. Neumayer and S. Morgera

¹Department of Nephrology, ²Department of Infectious Disease, Campus Charité Mitte, Charité-Universitätsmedizin Berlin and ³Anesthesiology Clinic, University of Düsseldorf, Germany
Background: The use of trisodium-citrate for regional anticoagulation of the extracorporal circuit during renal replacement therapy (RRT) has received increased interest, particularly in critically ill patients with increased risk of bleeding. Continuous renal replacement therapies are the most extensively investigated and used procedures in this regard. However, when patients recover from critical illness, RRT is often switched to intermittent procedures. In this prospective study, we investigated the efficacy and safety of citrate anticoagulation during intermittent hemodialysis (IHD) performed with a standard roller blood pump device. Methods: We treated 11 critically ill patients with acute renal failure. These patients received a total of 31 intermittent IHD treatments. The targeted IHD treatment time was 6 h (4.5 l/h treatment dose). For anticoagulation, a 4% trisodium-citrate solution was continuously infused into the arterial line of the extracorporeal circuit. A calcium-free, lactate-based dialysis solution was used in all treatment procedures. Calcium was continuously substituted via a separate central line. Electrolyte and acid-base changes as well as the cardiovascular hemodynamics were analyzed. Results: All patients achieved the targeted filter life time. Filter clotting did not occur. Electrolytes and acid base values were well-maintained throughout the study period. Particularly metabolic derangements were not observed. All treatments were hemodynamically well-tolerated. Conclusions: Intermittent hemodialysis with citrate anticoagulation can be safely applied in critically ill patients at high risk of bleeding.Correspondence to:
PD Dr. med. S. Morgera, Medizinische Klinik mit Schwerpunkt Nephrologie, CCM, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany
Email: [email protected]

Therapeutics

Ibuprofen sodium dihydrate, an ibuprofen formulation with improved absorption characteristics, provides faster and greater pain relief than ibuprofen acid

P. Schleier, A. Prochnau, A.M. Schmidt-Westhausen, H. Peters, J. Becker, T. Latz, J. Jackowski, E.U. Peters, G.E. Romanos, B. Zahn, J. Lüdemann, J. Maares and B. Petersen

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Volume 45 p. 89 - 97

Abstract

P. Schleier, A. Prochnau, A.M. Schmidt-Westhausen, H. Peters, J. Becker, T. Latz, J. Jackowski, E.U. Peters, G.E. Romanos, B. Zahn, J. Lüdemann, J. Maares and B. Petersen

¹Department of Maxillofacial Surgery/Plastic Surgery, Friedrich Schiller University, Jena, ²Department of Oral Surgery and Dental Radiology, Charité Universitätsmedizin Berlin, ³Department of Oral Surgery and Central Admittance, University Clinic of Düsseldorf, ⁴Department of Oral Surgery, School of Dental Medicine, University of Witten/Herdecke, ⁵Department of Oral Surgery and Implantology, University of Frankfurt am Main, Germany, ⁶Bayer Consumer Care AG, Basle, Switzerland, and ⁷Schlossweg ³, Grenzach-Wyhlen, Germany
Objective: The objective of this 6-hour study was to compare rate of pain relief, analgesic efficacy and tolerability of a novel ibuprofen formulation, ibuprofen sodium dihydrate, with that of ibuprofen acid in subjects with postoperative dental pain. Material and methods: The test formulation of ibuprofen sodium dihydrate (256 mg sodium salt) and the reference product both contain 200 mg ibuprofen. Subjects with moderate-to-severe pain after extraction of third molars were randomized to receive two tablets of either ibuprofen sodium dihydrate (198 subjects) or ibuprofen (198 subjects) in this double-blind, multicenter trial. Pain was measured using traditional descriptor scales and onset of analgesia assessed using the stopwatch method. Results: Median time to substantial pain relief occurred 14 minutes earlier in the ibuprofen sodium dihydrate group (p < 0.001). The first sign of pain relief, an increase in relief and time until the pain was half gone occurred significantly earlier and faster in the ibuprofen sodium dihydrate-treated patients (p < 0.02 – 0.00003). Corresponding numbers needed to treat were in the range 5 – 11. Reduction in pain intensity was evident within 5 minutes (p < 0.01) in the ibuprofen sodium dihydrate group compared to 15 minutes in the ibuprofen group. Pain intensity was reduced to half after 30 and 57 minutes in the ibuprofen sodium dihydrate and ibuprofen groups, respectively (p < 0.025). The overall analgesic efficacy in terms of summed pain intensity differences (SPID), total pain relief (TOTPAR) and remedication times in the two groups were similar. Both treatments were well tolerated and no serious events occurred. Conclusion: Ibuprofen sodium dihydrate provides faster and more efficacious pain relief during the first hour after intake when compared to a conventional ibuprofen acid formulation. The tolerability profiles are similar.Correspondence to:
B. Petersen; Bayer Consumer Care AG, Peter Merian-Straße 84, Postbox, 4002 Basel, Switzerland
Email: [email protected]

Original Research

Plasma pharmacokinetics of daptomycin in critically ill patients with renal failure and undergoing CVVHD

D. Khadzhynov, T. Slowinski, I. Lieker, C. Spies, B. Puhlmann, T. König, A. Uhrig, K. Eggers, H.- H. Neumayer, F. Traunmüller, C. Joukhadar and H. Peters

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Volume 49 p. 656 - 665

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 49 – No. 11/2011 (656-665)

Plasma pharmacokinetics of daptomycin in critically ill patients with renal failure and undergoing CVVHD

D. Khadzhynov¹, T. Slowinski¹, I. Lieker¹, C. Spies², B. Puhlmann², T. König², A. Uhrig³, K. Eggers⁴, H.-H. Neumayer¹, F. Traunmüller⁵,⁶, C. Joukhadar⁵,⁶ and H. Peters¹

¹Department of Nephrology, ²Department of Anaesthesia, ³Department of Infectious Disease, ⁴Department of Cardiology, Charité Universitätsmedizin Berlin, Charité Campus Mitte, Humboldt University Berlin, Germany, ⁵J&P MEDICAL RESEARCH Ltd., Vienna, Austria and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA, USA, and ⁶Medical University of Graz, Graz, Austria
Background: Daptomycin is a novel antibiotic with primarily renal elimination. Methods: In an open-label, prospective trial, the pharmacokinetics of daptomycin after single (8 mg/kg BW) and multiple intravenous doses (4 mg/kg BW) at steady state were determined in critically ill, dialysis-dependent patients treated with continuous veno-venous hemodialysis (CVVHD). Daptomycin levels were determined by HPLC. Subjects with normal renal function received one dose of 4 mg/kg BW of daptomycin. Results: In the normal controls, daptomycin administration resulted in a mean maximum concentration (C_max) of 60.7 ± 10.7 mg/l and an area under the time-versus-concentration curve from 0 to 24 h (AUC_0–24) of 402 ± 56 mg × h/l. In the CVVHD-treated patients, a loading dose of 8 mg/kg lead to C_max of 87.5 ± 15.0 mg/l, AUC_0–24 of 537 ± 97 mg × h/l and AUC_24–48 of 193 ± 69 mg × h/l, respectively. After multiple doses of 4 mg/kg every 48 h, C_max was 41.8 ± 5.0 mg/l, AUC_0–24 302 ± 43 mg × h/l and AUC_24–48h 102 ± 24 mg × h/l, respectively. Approximately 40% of the daptomycin dose administered was removed by CVVHD. Mean plasma half-lives of daptomycin in patients were 2 – 3 times longer than in healthy controls. Conclusions: The dosing regimen of 4 mg/kg TBW of daptomycin administered to CVVHD patients every 48 h is inappropriate to achieve effective antimicrobial plasma concentrations of daptomycin in the second half of the dosing interval (24 – 48 h). Doses of ≥ 4 mg/kg TBW administered intravenously every 24 h are necessary in CVVHD patients to assure that plasma daptomycin levels are comparably high to subjects with normal renal function and to avoid underdosing.Correspondence to:
H. Peters, MD
Department of Nephrology
Charité Universitätsmedizin Berlin
Humboldt University
Charitéplatz 1
10117 Berlin, Germany
Email: [email protected]

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