Use of Water Warming/Cooling Garment to Maintain a Constant Intraoperative Core Target Temperature in Patients Undergoing Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC): A Proof-of-Concept Study

Early Phase 1

Withdrawn

• Conditions: Hyperthermic Intraperitoneal
• Interventions: Device: Allon System

• Registration Number: NCT05474352
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To look at the feasibility of using a water warming/cooling garment (called the ALLON system) to maintain a target body temperature during surgery and chemotherapy perfusion (a method of pouring chemotherapy throughout your abdominal cavity) without overheating or overcooling your body.

Detailed Description

Objectives:

Primary Objectives:

To evaluate the feasibility of using a water warming/cooling garment (Allon system) to achieve and maintain a bladder temperature of ≥38°C for at least 30 minutes or longer during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy while avoiding core (esophageal) hyperthermia (≥39.5°C).

Secondary Objective:

To evaluate the safety for all study participants when using of the Allon system strategy in achieving and maintaining a bladder temperature of ≥38°C for at least 30 minutes or longer during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy while avoiding core hyperthermia (≥39°C)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-06-14
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-26
• Status Verified: 2023-05
• Primary Completion: 2023-05-03
• Study Completion: 2023-05-03
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adults patients (>18 years old)
• Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy with an expected duration of perfusion longer than 60 minutes
• Signed informed consent

Exclusion criteria:

• America Society of Anesthesiology (ASA)physical status >4
• Patient undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for recurrent disease.
• Patients with open wounds
• Patients with a history of thermoregulatory diseases such as spinal cord injury, thyroid disease, and malignant hyperthermia.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALLON System	Allon System	The ALLON system water garment, is like a large apron that covers your body. There are tubes that run throughout the water garment, which allow warm liquid to flow so that the garment keeps the participant warm. The ALLON system water garment will be filled with warm water.

Primary Outcome Measures

Name	Time	Method
Number of Patients to achieve and maintain a bladder temperature of ≥38°C for at least 30 minutes or longer.	through HIPEC surgery (up to 4 hours)

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States