Proactive Temperature Management in CRS-HIPEC for Prevention of Delirium

Starting soon · Not applicable

Conditions studied: Pseudomyxoma Peritonei, Postoperative Delirium (POD)

In brief

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.

Key facts

Study ID

NCT07378371

Run by

Aerospace Center Hospital

People needed

174

Starts

2026-02-01

Expected to finish

2026-05-01

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Aerospace Center Hospital — Beijing, China

Full record on ClinicalTrials.gov

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