Proactive Temperature Management in CRS-HIPEC for Prevention of Delirium

NCT07378371 | Not Yet Recruiting

• 1 other identifier: XYin-HIPEC-2026-01
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pseudomyxoma Peritonei; Postoperative Delirium (POD)

Keywords

Cytoreductive Surgery; HIPEC; Hyperthermic Intraperitoneal Chemotherapy; Temperature Management; Goal-Directed Therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium

  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 .

  From ICU admission through postoperative day 7 (or hospital discharge, whichever occurs first)

Secondary Outcomes (10)

• 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

Study Arms (2)

GDTM Group

EXPERIMENTAL

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 .

Procedure: Proactive Goal-Directed Temperature Management

Usual Care Group

ACTIVE COMPARATOR

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 .

Procedure: Standard Reactive Temperature Management

Interventions

Proactive Goal-Directed Temperature Management PROCEDURE

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 .

GDTM Group

Standard Reactive Temperature Management PROCEDURE

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 .

Usual Care Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Aerospace Center Hospital: lead

Study Sites (1)

Aerospace Center Hospital

Beijing, China

Location

MeSH Terms

Conditions

Pseudomyxoma Peritonei; Emergence Delirium

Condition Hierarchy (Ancestors)

Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Xiangli Zheng

  Aerospace Center Hospital

  STUDY CHAIR

Central Study Contacts

Xinrui Yin

CONTACT

+86-13029315156; ahywvn@pku.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 30, 2026
• Study Start: February 1, 2026
• Primary Completion: March 20, 2026
• Study Completion: May 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CN (1)