Proactive Temperature Management and Delirium After Cytoreductive Surgery With HIPEC: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Delirium
研究概览
简要总结
This randomized controlled trial evaluates the efficacy of a proactive Goal-Directed Temperature Management (GDTM) protocol in reducing postoperative delirium among patients undergoing Cytoreductive Surgery (CRS) with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for pseudomyxoma peritonei.
CRS-HIPEC presents a unique physiological challenge characterized by a biphasic thermal trajectory: potential hypothermia during extensive surgery followed by rapid iatrogenic hyperthermia during perfusion. This study compares a standardized GDTM strategy-which incorporates strict normothermia maintenance and anticipatory pre-cooling prior to perfusion-against standard reactive thermal management. The primary objective is to determine if optimized thermoregulation can attenuate thermal variability and improve early neurocognitive recovery.
详细描述
Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) imposes a formidable physiologic burden, involving extensive resections and a distinctive thermal paradox. Patients typically experience a prolonged cytoreductive phase prone to inadvertent hypothermia, followed by protocol-driven hyperthermia during the perfusion phase. This rapid thermal fluctuation may disrupt blood-brain barrier integrity and amplify neuroinflammation, potentially contributing to postoperative delirium (POD).
Despite these risks, perioperative thermoregulation often remains reactive, with interventions initiated only after temperature thresholds are violated. Evidence-based recommendations for managing the iatrogenic heat load inherent to HIPEC remain undefined.
This single-center, parallel-group, randomized controlled trial aims to address this gap. Eligible adult patients scheduled for elective CRS-HIPEC are randomized to receive either proactive Goal-Directed Temperature Management (GDTM) or Usual Care. The GDTM protocol utilizes a phase-based algorithm, including specific targets for normothermia during resection and a "thermal buffer" created by anticipatory cooling prior to the hyperthermic phase. The Usual Care group receives standard reactive management where interventions are triggered primarily by observed threshold violations.
The primary endpoint is the incidence of POD within the first 7 postoperative days. Secondary endpoints include delirium-free days, intraoperative thermal exposure metrics, delayed neurocognitive recovery, and 30-day major complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged 18-80 years).
- •American Society of Anesthesiologists (ASA) physical status of I to III.
- •Scheduled for elective Cytoreductive Surgery (CRS) with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Pseudomyxoma Peritonei (PMP).
- •Written informed consent obtained from the participant or legally authorized representative.
排除标准
- •Known diagnosis of dementia, major neurocognitive disorder, or severe psychiatric illness (e.g., schizophrenia) documented in the medical record.
- •Acute central nervous system pathology likely to confound delirium assessment (e.g., recent stroke, active seizure disorder, or traumatic brain injury).
- •Severe sensory or language barriers precluding valid cognitive screening (e.g., profound deafness or blindness, or language barriers not correctable with translation).
- •Preoperative coma, mechanical ventilation, or deep sedation precluding reliable baseline assessment.
- •Emergency surgery or repeat CRS-HIPEC during the same hospital admission.
- •History of alcohol or substance abuse likely to precipitate withdrawal symptoms.
研究组 & 干预措施
GDTM Group
Participants assigned to this group receive a protocolized, phase-based temperature management algorithm. This includes strict normothermia maintenance during cytoreduction, anticipatory pre-cooling prior to HIPEC perfusion, and proactive cooling during the hyperthermic phase to attenuate thermal variability .
干预措施: Proactive Goal-Directed Temperature Management (Procedure)
Usual Care Group
Participants receive standard institutional thermal management characterized by a reactive approach. Therapeutic interventions (warming or cooling) are determined by the attending anesthesiologist based on observed threshold violations (e.g., core temperature <36.0°C or >38.5°C) rather than a prespecified goal-directed algorithm .
干预措施: Standard Reactive Temperature Management (Procedure)
结局指标
主要结局
Incidence of Postoperative Delirium
时间窗: From ICU admission through postoperative day 7 (or hospital discharge, whichever occurs first)
Delirium is assessed twice daily (08:00-10:00 and 18:00-20:00) using the Confusion Assessment Method for the ICU (CAM-ICU) for mechanically ventilated or ICU patients, and the standard CAM for ward patients. Postoperative delirium is defined as at least one positive CAM-ICU or CAM assessment during the assessment window .
次要结局
- Delirium- and Coma-Free Days (DCFDs)(Within 7 days postoperatively)
- Intraoperative Thermal Exposure (AUC >38.5°C)(From the initiation of HIPEC perfusion until the completion of perfusion, approximately 90 minutes.)
- 30-Day Major Complications Composite(Within 30 days postoperatively)
- Delayed Neurocognitive Recovery (DNR)(Discharge (or postoperative day 7) and 1 month postoperatively)
- Quality of Recovery (QoR-15 Score)(Postoperative days 1, 3, and 7)
- Postoperative Pain Intensity (NRS Score)(Postoperative days 1, 2, and 3)
- Length of Stay (ICU and Hospital)(From date of surgery until date of hospital discharge, assessed up to 30 days.)
- Cumulative Opioid Consumption(From the end of surgery up to 72 hours postoperatively.)
- Incidence of Severe Thermal Excursions(From the start of anesthesia induction until the end of surgery, approximately 10 hours)
- Incidence of Thermal-Related Adverse Events(From the end of surgery until hospital discharge, assessed up to 30 days.)
研究者
Xinrui Yin
Principal Investigator
Aerospace Center Hospital