Safety of intranasal insulin administration in patients undergoing cardiovascular surgery: An open-label, nonrandomized, dose-escalation studyCentral MessagePerspective

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Název: Safety of intranasal insulin administration in patients undergoing cardiovascular surgery: An open-label, nonrandomized, dose-escalation studyCentral MessagePerspective
Autoři: Yosuke Nakadate, MD, PhD, Akiko Kawakami, MD, PhD, Takeshi Oguchi, MD, PhD, Keisuke Omiya, MD, PhD, Hiroyuki Nakajima, MD, PhD, Hiroshi Yokomichi, MD, PhD, DPH, Hiroaki Sato, MD, PhD, Thomas Schricker, MD, PhD, Takashi Matsukawa, MD, PhD
Zdroj: JTCVS Open, Vol 17, Iss , Pp 172-182 (2024)
Informace o vydavateli: Elsevier, 2024.
Rok vydání: 2024
Sbírka: LCC:Diseases of the circulatory (Cardiovascular) system
LCC:Surgery
Témata: cardiac surgery, hypoglycemia, intranasal insulin administration, serum insulin concentration, postoperative delirium, Diseases of the circulatory (Cardiovascular) system, RC666-701, Surgery, RD1-811
Popis: Objective: This study aimed to determine the maximum safe dose of intranasal insulin administration during cardiac surgery. Methods: This open-label, Phase 1, single-center, dose-escalation clinical trial recruited patients scheduled to undergo elective cardiac surgery or major vascular surgery requiring cardiopulmonary bypass between February and September 2021. They were grouped into 5 dose-escalation cohorts and administered 0, 40, 80, 160, and 240 IU insulin (n = 6 in each group) via a metered nasal dispenser after the induction of general anesthesia. Blood samples were collected at 10-minute intervals for the first 60 minutes and at 30-minute intervals thereafter. Hypoglycemia was defined as a blood glucose level
Druh dokumentu: article
Popis souboru: electronic resource
Jazyk: English
ISSN: 2666-2736
Relation: http://www.sciencedirect.com/science/article/pii/S2666273623004175; https://doaj.org/toc/2666-2736
DOI: 10.1016/j.xjon.2023.11.020
Přístupová URL adresa: https://doaj.org/article/049bafa0f0c84b1e8911dbe2b0625650
Přístupové číslo: edsdoj.049bafa0f0c84b1e8911dbe2b0625650
Databáze: Directory of Open Access Journals
Popis
Abstrakt:Objective: This study aimed to determine the maximum safe dose of intranasal insulin administration during cardiac surgery. Methods: This open-label, Phase 1, single-center, dose-escalation clinical trial recruited patients scheduled to undergo elective cardiac surgery or major vascular surgery requiring cardiopulmonary bypass between February and September 2021. They were grouped into 5 dose-escalation cohorts and administered 0, 40, 80, 160, and 240 IU insulin (n = 6 in each group) via a metered nasal dispenser after the induction of general anesthesia. Blood samples were collected at 10-minute intervals for the first 60 minutes and at 30-minute intervals thereafter. Hypoglycemia was defined as a blood glucose level
ISSN:26662736
DOI:10.1016/j.xjon.2023.11.020