Proactive Temperature Management in CRS-HIPEC for Prevention of Delirium
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAerospace Center Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (aged 18-80 years).
Disqualifiers
Known diagnosis of dementia, major neurocognitive disorder, or severe psychiatric illness (e.g., schizophrenia) documented in the medical record.
Trial design
Design model
Parallel
Treatments tested in this trial
Proactive Goal-Directed Temperature Management
Procedure/SurgeryThe 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
Procedure/SurgeryHypothermia 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 .
Treatment groups
174 Participants
are divided into 2 treatment groupsGroup A: GDTM GroupExperimental treatment 1 intervention
Group B: Usual Care GroupActive comparator 1 intervention
Trial outcomes
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 .
Time frame
From ICU admission through postoperative day 7 (or hospital discharge, whichever occurs first)Secondary outcomes
1
Delirium- and Coma-Free Days (DCFDs)
Calculated as the number of days alive and free of both delirium and coma. A day is scored as "free" only if the patient is alive, not comatose, and delirium-negative on all assessments .
Time frame
Within 7 days postoperatively2
Intraoperative Thermal Exposure (AUC >38.5°C)
Calculated as the Area Under the Curve (AUC) for core temperature \>38.5°C during the HIPEC phase to quantify physiologic thermal load.
Time frame
From the initiation of HIPEC perfusion until the completion of perfusion, approximately 90 minutes.3
30-Day Major Complications Composite
A composite of Clavien-Dindo grade III-V complications (including mortality).
Time frame
Within 30 days postoperatively4
Delayed Neurocognitive Recovery (DNR)
Assessed using the Montreal Cognitive Assessment (MoCA). DNR is defined as a decline in MoCA score of ≥1 SD from the preoperative baseline mean, adjusted for age and education .
Time frame
Discharge (or postoperative day 7) and 1 month postoperativelySponsors and contacts
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Source ClinicalTrials.gov
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