Pseudomyxoma PeritoneiNCT07378371
Proactive Temperature Management in CRS-HIPEC for Prevention of Delirium
A study testing Proactive Goal-Directed Temperature Management and Standard Reactive Temperature Management in people with Pseudomyxoma Peritonei and Postoperative Delirium (POD), run by Aerospace Center Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pseudomyxoma Peritonei, Postoperative Delirium (POD)
- What is being tested?
- Proactive Goal-Directed Temperature Management and Standard Reactive Temperature Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Aerospace Center Hospital
Beijing
Xinrui Yin, +86-13029315156, ahywvn@pku.org.cn
About this study
Official title: Proactive Temperature Management and Delirium After Cytoreductive Surgery With HIPEC: A Randomized Controlled 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.
Read the 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.
- Being tested
- Proactive Goal-Directed Temperature Management, Standard Reactive Temperature Management
- Keywords
- Cytoreductive Surgery, HIPEC, Hyperthermic Intraperitoneal Chemotherapy, Temperature Management, Goal-Directed Therapy
- Medical subject headings
- Pseudomyxoma Peritonei, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive Goal-Directed Temperature ManagementProcedure or surgery
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 ManagementProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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 . Receives: Procedure: Standard Reactive Temperature Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: From ICU admission through postoperative day 7 (or hospital discharge, whichever occurs first)
Secondary outcomes (10)
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 .
Measured: Within 7 days postoperatively
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.
Measured: From the initiation of HIPEC perfusion until the completion of perfusion, approximately 90 minutes.
30-Day Major Complications Composite
A composite of Clavien-Dindo grade III-V complications (including mortality).
Measured: Within 30 days postoperatively
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 .
Measured: Discharge (or postoperative day 7) and 1 month postoperatively
Quality of Recovery (QoR-15 Score)
Evaluated using the QoR-15 questionnaire, a 15-item patient-reported outcome measure. Scores range from 0 to 150, with higher scores indicating better quality of recovery.
Measured: Postoperative days 1, 3, and 7
Postoperative Pain Intensity (NRS Score)
Assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: Postoperative days 1, 2, and 3
Length of Stay (ICU and Hospital)
Duration of stay in the Intensive Care Unit (ICU) and total hospital length of stay from surgery to discharge
Measured: From date of surgery until date of hospital discharge, assessed up to 30 days.
Cumulative Opioid Consumption
Total postoperative opioid consumption converted to morphine milligram equivalents (MME).
Measured: From the end of surgery up to 72 hours postoperatively.
Incidence of Severe Thermal Excursions
Defined as core temperature <35.0°C (severe hypothermia) or >39.0°C (severe hyperthermia)
Measured: From the start of anesthesia induction until the end of surgery, approximately 10 hours
Incidence of Thermal-Related Adverse Events
Includes postoperative shivering requiring pharmacologic treatment and device-related skin injury (e.g., thermal burns, cold injury, pressure ulcers).
Measured: From the end of surgery until hospital discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomyxoma PeritoneiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aerospace Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinrui Yin, Aerospace Center Hospital
- Investigators
- Xiangli Zheng, Study chair, Aerospace Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378371
- Sponsor's protocol ID
- XYin-HIPEC-2026-01
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Temperature Management and Delirium After Cytoreductive Surgery With HIPEC: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07378371
- Acronym / sponsor ID
- XYin-HIPEC-2026-01
- Keywords
- Cytoreductive Surgery, HIPEC, Hyperthermic Intraperitoneal Chemotherapy, Temperature Management, Goal-Directed Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Aerospace Center HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDTM Group | Experimental | Procedure: Proactive Goal-Directed Temperature ManagementParticipants 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 . |
| Usual Care Group | Active comparator | Procedure: Standard Reactive Temperature ManagementParticipants 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 . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive Goal-Directed Temperature ManagementThe 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 or surgery | GDTM Group |
| Standard Reactive Temperature ManagementHypothermia 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 . | Procedure or surgery | Usual Care Group |
Primary outcome
Incidence of Postoperative Delirium
Time frame: 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 .
10 secondary outcomes
Delirium- and Coma-Free Days (DCFDs)
Time frame: Within 7 days postoperatively
Intraoperative Thermal Exposure (AUC >38.5°C)
Time frame: From the initiation of HIPEC perfusion until the completion of perfusion, approximately 90 minutes.
30-Day Major Complications Composite
Time frame: Within 30 days postoperatively
Delayed Neurocognitive Recovery (DNR)
Time frame: Discharge (or postoperative day 7) and 1 month postoperatively
Quality of Recovery (QoR-15 Score)
Time frame: Postoperative days 1, 3, and 7
Postoperative Pain Intensity (NRS Score)
Time frame: Postoperative days 1, 2, and 3
Length of Stay (ICU and Hospital)
Time frame: From date of surgery until date of hospital discharge, assessed up to 30 days.
Cumulative Opioid Consumption
Time frame: From the end of surgery up to 72 hours postoperatively.
Incidence of Severe Thermal Excursions
Time frame: From the start of anesthesia induction until the end of surgery, approximately 10 hours
Incidence of Thermal-Related Adverse Events
Time frame: From the end of surgery until hospital discharge, assessed up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiangli Zheng study chair
Aerospace Center Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive Goal-Directed Temperature Management and Standard Reactive Temperature Management in people with Pseudomyxoma Peritonei and Postoperative Delirium (POD), run by Aerospace Center Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinrui Yin (+86-13029315156, ahywvn@pku.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium (time frame: From ICU admission through postoperative day 7 (or hospital discharge, whichever occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.