Optimal target blood pressure in elderly with septic shock (OPTPRESS) trial: study protocol for a randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; p. 799
• Main Authors: Endo, Akira, Yamakawa, Kazuma, Tagami, Takashi, Umemura, Yutaka, Takahashi, Kyosuke, Nagasawa, Hiroki, Araki, Yuichi, Kojima, Mitsuaki, Sera, Toshiki, Yagi, Masayuki, Yamamoto, Ryo, Takahashi, Jiro, Nakane, Masaki, Takeda, Chikashi, Narita, Chihiro, Kazuma, Satoshi, Okura, Hiroko, Takahashi, Hiroyuki, Wada, Takeshi, Tahara, Shu, Matsuoka, Ayaka, Masaki, Todani, Shiraishi, Atsushi, Shimoyama, Keiichiro, Yokokawa, Yuta, Nakamura, Rintaro, Sageshima, Hisako, Yanagida, Yuichiro, Takahashi, Kunihiko, Otomo, Yasuhiro
• Format: Journal Article
• Language: English
• Published: London BioMed Central Ltd 24-09-2022; BioMed Central; BMC
• Subjects: Aged patients; Antibiotics; Arterial pressure; Blood pressure; Care and treatment; Catecholamines; Clinical practice guidelines; Clinical trials; Colleges & universities; Critical care; Demographic aspects; Emergency medical care; Geriatrics; Hemodynamics; Hospitals; Hypertension; Hypotension; Intensive care; Medicine; Mortality; Older people; Patients; Regulation; Renal replacement therapy; Sepsis; Septic shock; Study Protocol; Vasoconstrictor agents; Japan
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06732-9

Abstract
Background
Hemodynamic stabilization is a core component in the resuscitation of septic shock. However, the optimal target blood pressure remains debatable. Previous randomized controlled trials suggested that uniformly adopting a target mean arterial pressure (MAP) higher than 65 mmHg for all adult septic shock patients would not be beneficial; however, it has also been proposed that higher target MAP may be beneficial for elderly patients, especially those with arteriosclerosis.
Methods
A multicenter, pragmatic single-blind randomized controlled trial will be conducted to compare target MAP of 80–85 mmHg (high-target) and 65–70 mmHg (control) in the resuscitation of septic shock patients admitted to 28 hospitals in Japan. Patients with septic shock aged ≥65 years are randomly assigned to the high-target or control groups. The target MAP shall be maintained for 72 h after randomization or until vasopressors are no longer needed to improve patients’ condition. To minimize the adverse effects related to catecholamines, if norepinephrine dose of ≥ 0.1 μg/kg/min is needed to maintain the target MAP, vasopressin will be initiated. Other therapeutic approaches, including fluid administration, hydrocortisone use, and antibiotic choice, will be determined by the physician in charge based on the latest clinical guidelines. The primary outcome is all-cause mortality at 90 days after randomization.
Discussion
The result of this trial will provide great insight on the resuscitation strategy for septic shock in the era of global aged society. Also, it will provide the better understanding on the importance of individualized treatment strategy in hemodynamic management in critically ill patients.
Trial registration
UMIN Clinical Trials Registry; UMIN000041775. Registered 13 September 2020.