Impact of a new balanced gelatine on electrolytes and pH in the perioperative care
| Autor: | Mandy Ledinko, Gösta Lotz, Patrick Meybohm, Gernot Marx, Rolf Rossaint, Achim W. Schindler, Tobias Schuerholz, Kai Zacharowski |
|---|---|
| Přispěvatelé: | Puebla, Iratxe |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Adolescent Science medicine.medical_treatment Plasma Substitutes Water-Electrolyte Imbalance Hemodynamics Renal function Electrolyte Acid-Base Imbalance Perioperative Care Hydroxyethyl Starch Derivatives 03 medical and health sciences Electrolytes Young Adult 0302 clinical medicine Chlorides 030202 anesthesiology Germany Abdomen Medicine Serum chloride Humans 030212 general & internal medicine ddc:610 Aged Aged 80 and over Multidisciplinary business.industry Central venous pressure Hydrogen-Ion Concentration Middle Aged Water-Electrolyte Balance Anesthesia Fluid Therapy Gelatin Base excess Female business Fluid replacement Abdominal surgery Research Article |
| Zdroj: | PLoS ONE PLoS ONE, Vol 14, Iss 4, p e0213057 (2019) |
| ISSN: | 1932-6203 |
| Popis: | IntroductionBalanced fluid replacement solutions can possibly reduce the risks for electrolyte imbalances, for acid-base imbalances, and thus for renal failure. To assess the intraoperative change of base excess (BE) and chloride in serum after treatment with either a balanced gelatine/electrolyte solution or a non-balanced gelatine/electrolyte solution, a prospective, controlled, randomized, double-blind, dual centre phase III study was conducted in two tertiary care university hospitals in Germany.Material and methods40 patients of both sexes, aged 18 to 90 years, who were scheduled to undergo elective abdominal surgery with assumed intraoperative volume requirement of at least 15 mL/kg body weight gelatine solution were included. Administration of study drug was performed intravenously according to patients need. The trigger for volume replacement was a central venous pressure (CVP) minus positive end-expiratory pressure (PEEP) 65 mmHg.ResultsThe primary endpoints, intraoperative changes of base excess -2.59 ± 2.25 (median: -2.65) mmol/L (balanced group) and -4.79 ± 2.38 (median: -4.70) mmol/L (non-balanced group)) or serum chloride 2.4 ± 1.9 (median: 3.0) mmol/L and 5.2 ± 3.1 (median: 5.0) mmol/L were significantly different (p = 0.0117 and p = 0.0045, respectively). In both groups (each n = 20) the investigational product administration in terms of volume and infusion rate was comparable throughout the course of the study, i.e. before, during and after surgery.DiscussionBalanced gelatine solution 4% combined with a balanced electrolyte solution demonstrated significant smaller impact on blood gas analytic parameters in the primary endpoints BE and serum chloride when compared to a non-balanced gelatine solution 4% combined with NaCl 0.9%. No marked treatment differences were observed with respect to haemodynamics, coagulation and renal function.Trial registrationClinicalTrials.gov (NCT01515397) and clinicaltrialsregister.eu, EudraCT number 2010-018524-58. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
| Nepřihlášeným uživatelům se plný text nezobrazuje | K zobrazení výsledku je třeba se přihlásit. |