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Preoperative nutritional optimization and physical exercise for patients scheduled for elective implantation for a left-ventricular assist device — The PROPER-LVAD study

Please always quote using this URN: urn:nbn:de:bvb:20-opus-288317
  • Background: Prehabilitation is gaining increasing interest and shows promising effects on short- and long-term outcomes among patients undergoing major surgery. The effect of multimodal, interdisciplinary prehabilitation has not yet been studied in patients with severe heart failure scheduled for the implantation of a left-ventricular assist device (LVAD). Methods: This randomized controlled multi-center study evaluates the effect of preoperative combined optimization of nutritional and functional status. Patients in the intervention group areBackground: Prehabilitation is gaining increasing interest and shows promising effects on short- and long-term outcomes among patients undergoing major surgery. The effect of multimodal, interdisciplinary prehabilitation has not yet been studied in patients with severe heart failure scheduled for the implantation of a left-ventricular assist device (LVAD). Methods: This randomized controlled multi-center study evaluates the effect of preoperative combined optimization of nutritional and functional status. Patients in the intervention group are prescribed daily in-bed cycling and oral nutrition supplements (ONS) from study inclusion until the day before LVAD-implantation. Patients in the control group receive standard of care treatment. The primary outcomes for the pilot study that involves 48 patients are safety (occurrence of adverse events), efficacy (group separation regarding the intake of macronutrients), feasibility of the trial protocol (compliance (percentage of received interventions) and confirmation of recruitment rates. Secondary outcomes include longitudinal measurements of muscle mass, muscle strength, physical function and quality of life, next to traditional clinical outcomes (30-day mortality, hospital and ICU length of stay, duration of mechanical ventilation and number of complications and infections). If the pilot study is successful, a larger confirmatory, international multicenter study is warranted.show moreshow less

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Metadaten
Author: Aileen Hill, Vera von Dossow, Daren K. Heyland, Rolf Rossaint, Patrick MeybohmORCiD, Henrik Fox, Michiel Morshuis, Gunnar Elke, Bernd Panholzer, Assad Haneya, Andreas Böning, Bernd Niemann, Rashad Zayat, Ajay Moza, Christian Stoppe
URN:urn:nbn:de:bvb:20-opus-288317
Document Type:Journal article
Faculties:Medizinische Fakultät / Klinik und Poliklinik für Anästhesiologie (ab 2004)
Language:English
Parent Title (English):Surgeries
ISSN:2673-4095
Year of Completion:2022
Volume:3
Issue:4
First Page:284
Last Page:296
Source:Surgeries (2022) 3:4, 284-296. https://doi.org/10.3390/surgeries3040031
DOI:https://doi.org/10.3390/surgeries3040031
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Tag:clinical trial; in-bed cycling; left-ventricular assist device; medical nutrition therapy; oral nutrition supplements; prehabilitation; trial protocol
Release Date:2023/09/22
Date of first Publication:2022/09/30
Note:
Funding: This investigator-initiated trial is supported by a grant from Fresenius Kabi Deutschland (Fresenius Kabi Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg). The oral nutrition supplements (Fresubin PRO®) are provided by Fresenius Kabi Germany.
Licence (German):License LogoCC BY: Creative-Commons-Lizenz: Namensnennung 4.0 International