Intelligent thermoregulation strategy versus routine thermal management on myocardial injury after noncardiac surgery during gastrointestinal tumor resection in elderly patients (SAGE): a multicenter, parallel-group, superiority trial.
9 affiliations
- 1Department of Anesthesiology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China.
- 2Postdoctoral Station of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
- 3Department of Anesthesiology, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Hunan, China.
- 4Department of Anesthesiology, Hunan Cancer Hospital, Changsha, China.
- 5Department of Anesthesiology, Huadong Hospital, Fudan University, Shanghai, China.
- 6Department of Anesthesiology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
- 7Department of Anesthesiology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China.
- 8Department of Anesthesiology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.
- 9Department of Gastrointestinal Surgery, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Abstract
Background
Inadvertent perioperative hypothermia is associated with adverse cardiovascular outcomes, but adequately powered trials using high-sensitivity troponin endpoints is lacking. The SAGE trial evaluates whether an intelligent, closed-loop thermoregulation strategy reduces myocardial injury after noncardiac surgery (MINS) in high-risk elderly patients.Methods
This prospective, multicenter, parallel-group, randomized controlled superiority trial conducted at seven tertiary hospitals in China. Participants aged ≥65 years scheduled for elective gastrointestinal tumor resection under general anesthesia are randomly assigned (1:1) to intelligent closed-loop warming (target 36.8 °C, upper limit 37.0 °C) or routine thermal management (active warming only if core temperature ≤35.5 °C). The primary outcome is the incidence of MINS within the first 2 postoperative days , adjudicated using high-sensitivity troponin thresholds per AHA criteria. Secondary outcomes include surgical site infection, transfusion requirement, hypothermia burden, emergence delirium, delayed emergence, and postoperative shivering. With 695 participants per group (total 1,390, accounting for 10% dropout), the trial has 80% power at a one-sided significance level of 0.05 to detect a 6 absolute percentage point reduction in MINS (12% to 6%) with a superiority margin of -2 percentage points.Discussion
The SAGE trial is designed to generate new evidence on the relationship between intraoperative hypothermia exposure and postoperative cardiovascular complications. It will evaluate whether closed-loop targeted normothermia reduces myocardial injury and will explore hypothermia exposure thresholds that may inform individualized perioperative management for geriatric surgical patients.Trial acronym
Intelligent Thermoregulation Strategy for Advanced-Age Elders undergoing gastrointestinal tumor resection (SAGE).Trial registration
Chinese Clinical Trial Registry (ChiCTR), identifier: ChiCTR2600117264. Registered on January 21, 2026 (http://www.chictr.org.cn).
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BibTeX
@article{ding2026intelligent,
title = {{Intelligent thermoregulation strategy versus routine thermal management on myocardial injury after noncardiac surgery during gastrointestinal tumor resection in elderly patients (SAGE): a multicenter, parallel-group, superiority trial.}},
author = {Zhendong Ding and Yuting Wang and Huiling Tan and Jitong Liu and Ji Xiao and Jianghong Zhao and Xixue Zhang and Xihua Lu and Shibiao Chen and Peng Li and Yi Zhang and Saiying Wang and Lan Li and Yongzhong Tang and Qin Liao and Wen Ouyang},
journal = {Annals of medicine},
year = {2026},
month = oct,
doi = {10.1080/07853890.2026.2732429},
url = {https://europepmc.org/article/MED/42864943},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Intelligent thermoregulation strategy versus routine thermal management on myocardial injury after noncardiac surgery during gastrointestinal tumor resection in elderly patients (SAGE): a multicenter, parallel-group, superiority trial.
AU - Zhendong Ding
AU - Yuting Wang
AU - Huiling Tan
AU - Jitong Liu
AU - Ji Xiao
AU - Jianghong Zhao
AU - Xixue Zhang
AU - Xihua Lu
AU - Shibiao Chen
AU - Peng Li
AU - Yi Zhang
AU - Saiying Wang
AU - Lan Li
AU - Yongzhong Tang
AU - Qin Liao
AU - Wen Ouyang
PY - 2026
DA - 2026/10/12
JO - Annals of medicine
DO - 10.1080/07853890.2026.2732429
UR - https://europepmc.org/article/MED/42864943
AB - Background Inadvertent perioperative hypothermia is associated with adverse cardiovascular outcomes, but adequately powered trials using high-sensitivity troponin endpoints is lacking. The SAGE trial evaluates whether an intelligent, closed-loop thermoregulation strategy reduces myocardial injury after noncardiac surgery (MINS) in high-risk elderly patients.Methods This prospective, multicenter, parallel-group, randomized controlled superiority trial conducted at seven tertiary hospitals in China. Participants aged ≥65 years scheduled for elective gastrointestinal tumor resection under general anesthesia are randomly assigned (1:1) to intelligent closed-loop warming (target 36.8 °C, upper limit 37.0 °C) or routine thermal management (active warming only if core temperature ≤35.5 °C). The primary outcome is the incidence of MINS within the first 2 postoperative days , adjudicated using high-sensitivity troponin thresholds per AHA criteria. Secondary outcomes include surgical site infection, transfusion requirement, hypothermia burden, emergence delirium, delayed emergence, and postoperative shivering. With 695 participants per group (total 1,390, accounting for 10% dropout), the trial has 80% power at a one-sided significance level of 0.05 to detect a 6 absolute percentage point reduction in MINS (12% to 6%) with a superiority margin of -2 percentage points.Discussion The SAGE trial is designed to generate new evidence on the relationship between intraoperative hypothermia exposure and postoperative cardiovascular complications. It will evaluate whether closed-loop targeted normothermia reduces myocardial injury and will explore hypothermia exposure thresholds that may inform individualized perioperative management for geriatric surgical patients.Trial acronym Intelligent Thermoregulation Strategy for Advanced-Age Elders undergoing gastrointestinal tumor resection (SAGE).Trial registration Chinese Clinical Trial Registry (ChiCTR), identifier: ChiCTR2600117264. Registered on January 21, 2026 (http://www.chictr.org.cn).
SN - 0785-3890
SN - 1365-2060
ER -