Proactive Goal-Directed Temperature ManagementStandard Reactive Temperature Management
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 .
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 .
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Incidence of Postoperative Delirium — 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 .
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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