G Haisch1, J Boldt, C Krebs, S Suttner, A Lehmann, F Isgro. 1. Department of Anesthesiology and Intensive Care Medicine, and Clinic of Cardiac Surgery, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany.
Abstract
OBJECTIVE: To compare volume therapy with HES 130/0.4, a new hydroxyethylstarch (HES) solution with a gelatin-based fluid replacement strategy. DESIGN: Prospective, randomized, safety study. SETTING:Urban, university-affiliated hospital (single institution). PARTICIPANTS: Forty-two patients undergoing elective cardiac surgery. INTERVENTIONS: Patients were prospectively randomized into 2 groups: In group 1 (n = 21), gelatin was given perioperatively for volume support until the 1st postoperative day to keep the central venous pressure (CVP) between 10 and 14 mmHg; in group 2 (n = 21) HES 130/0.4 was administered using the same protocol as in group 1. MEASUREMENTS AND MAIN RESULTS:Standard coagulation variables and modified thromboelastography (TEG) were used. Using different activators for extrinsic and intrinsic activation and heparin inactivation by heparinase, the onset of coagulation (coagulation time), kinetics of clot formation (clot formation time), and maximum clot firmness were measured. Measurements were performed after induction of anesthesia (T0), at the end of surgery (T1), 4 hours after surgery (T2), and on the morning of the 1st postoperative day (T3). A total of 3310 +/- 810 mL of gelatin and 3070 +/- 570 mL of HES 130/0.4 were used in the 2 groups during the study period. The 2 groups did not differ with regard to postoperative bleeding or in use of packed red blood cells or fresh frozen plasma. Standard coagulation variables were similar between the 2 groups. All TEG variables were within the normal range at baseline. Coagulation time and clot formation time data were significantly elevated after surgery and in the intensive care unit, without showing specific differences between the 2 volume replacement groups. Intrinsic TEG and heparinase TEG clot formation times remained significantly higher until the end of the study period. No differences were seen between HES-treated and gelatin-treated patients. CONCLUSIONS: Volume replacement with the new HES preparation was as safe as gelatin-based volume replacement with regard to coagulation in cardiac surgical patients. HES 130/0.4 is an alternative plasma substitute to treat volume deficits. Copyright 2001 by W.B. Saunders Company.
RCT Entities:
OBJECTIVE: To compare volume therapy with HES 130/0.4, a new hydroxyethylstarch (HES) solution with a gelatin-based fluid replacement strategy. DESIGN: Prospective, randomized, safety study. SETTING: Urban, university-affiliated hospital (single institution). PARTICIPANTS: Forty-two patients undergoing elective cardiac surgery. INTERVENTIONS:Patients were prospectively randomized into 2 groups: In group 1 (n = 21), gelatin was given perioperatively for volume support until the 1st postoperative day to keep the central venous pressure (CVP) between 10 and 14 mmHg; in group 2 (n = 21) HES 130/0.4 was administered using the same protocol as in group 1. MEASUREMENTS AND MAIN RESULTS: Standard coagulation variables and modified thromboelastography (TEG) were used. Using different activators for extrinsic and intrinsic activation and heparin inactivation by heparinase, the onset of coagulation (coagulation time), kinetics of clot formation (clot formation time), and maximum clot firmness were measured. Measurements were performed after induction of anesthesia (T0), at the end of surgery (T1), 4 hours after surgery (T2), and on the morning of the 1st postoperative day (T3). A total of 3310 +/- 810 mL of gelatin and 3070 +/- 570 mL of HES 130/0.4 were used in the 2 groups during the study period. The 2 groups did not differ with regard to postoperative bleeding or in use of packed red blood cells or fresh frozen plasma. Standard coagulation variables were similar between the 2 groups. All TEG variables were within the normal range at baseline. Coagulation time and clot formation time data were significantly elevated after surgery and in the intensive care unit, without showing specific differences between the 2 volume replacement groups. Intrinsic TEG and heparinase TEG clot formation times remained significantly higher until the end of the study period. No differences were seen between HES-treated and gelatin-treated patients. CONCLUSIONS: Volume replacement with the new HES preparation was as safe as gelatin-based volume replacement with regard to coagulation in cardiac surgical patients. HES 130/0.4 is an alternative plasma substitute to treat volume deficits. Copyright 2001 by W.B. Saunders Company.
Authors: Michael Winterhalter; P Malinski; O Danzeisen; S Sixt; E Monaca; T Jüttner; M Peiper; P Kienbaum; A Koester; N Rahe-Meyer Journal: Eur J Med Res Date: 2010-09-24 Impact factor: 2.175