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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hyperthermic Intraperitoneal
• Intervention / Treatment: Device: Allon System

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)

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Md Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: Allon System; Water garments (Allon system) already pre-filled with warm water will be set up before induction of anesthesia. After the induction of general anesthesia, the water garment will cover the lower and upper extremities, the lateral portion of the chest, and the entire back of the patient, which accounts for 70% of the body surface. The water garment will be opened temporarily on the upper extremities for intravenous access and arterial line placement and will be continued intraoperatively until the patient is transferred from the OR table to the stretcher

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Maria F Ramirez, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever
• Other Study ID Numbers: 2022-0159; NCI-2022-05348 (Other Identifier: NCI CTRP-Clinical Trials Reporting Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes