NCT07378371

Proactive Temperature Management in CRS-HIPEC for Prevention of Delirium

Proactive Temperature Management and Delirium After Cytoreductive Surgery With HIPEC: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Aerospace Center Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pseudomyxoma Peritonei
• Postoperative Delirium (POD)

Interventions

Type	Name	Description
PROCEDURE	Proactive Goal-Directed Temperature Management	The protocol consists of four phases: Cytoreductive Phase: Maintain core temperature 36.5-37.5°C. Pre-cooling Phase: Initiated \~30 min before HIPEC (e.g., during closure), targeting 36.0-36.3°C. HIPEC Phase: Proactive cooling to target 37.5-38.0°C; escalation triggered at 37.8°C. 4. Rewarming Phase: Restore 36.5-37.5°C prior to ICU transfer .
PROCEDURE	Standard Reactive Temperature Management	Hypothermia Management: Active warming initiated reactively only when core temperature falls below 36.0°C. Pre-cooling: No anticipatory pre-cooling is performed. 3. HIPEC Phase: Active cooling withheld unless core temperature exceeds standard safety thresholds (typically \>38.5°C) or for immediate safety indications .

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-03-20
• Completion: 2026-05-01
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

1 site across 1 country: China