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Effect of Heat Stress on Global LV Function in Anesthetized Humans

Primary Purpose

Hyperthermia, Cardiac Functional Disturbances During Surgery

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transesophageal Echocardiography

About this trial

This is an interventional supportive care trial for Hyperthermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

any patient presenting for hyperthermic intraperitoneal chemotherapy.

Exclusion Criteria:

Subjects less than 18 years old.
pregnant women
prisoners,
institutionalized individuals
Any patient with known contraindication to Transesophageal echocardiography.
Patients with known cardiac dysfunction prior to screening will be excluded.

Sites / Locations

University of California, San Diego

Outcomes

Primary Outcome Measures

Change in ejection fraction before and after hyperthermia

Secondary Outcome Measures

Transmitral inflow velocities before and after hyperthermia

Pulmonary venous inflow velocities before and during hyperthermia

Mitral annular tissue doppler velocities before and during hyperthermia

Full Information

NCT ID

NCT04553900

First Posted

September 11, 2020

Last Updated

September 17, 2020

Sponsor

University of California, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT04553900

Brief Title

Effect of Heat Stress on Global LV Function in Anesthetized Humans

Official Title

Effect of Heat Stress on Global LV Function in Anesthetized Humans

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

June 9, 2017 (Actual)

Primary Completion Date

December 6, 2019 (Actual)

Study Completion Date

December 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Recent data suggests that increased temperature improves inotropic function during systole and may improve diastolic function in healthy humans at rest, despite a reduction in left ventricular volume at end diastole. The effect of heat stress has not been reported in patients receiving general anesthesia and the impact of general anesthesia on these findings is not known. Trans-esophageal echocardiography will be used to measure parameters important to both systolic and diastolic function at temperature intervals of 1°C in patients undergoing "Heated Intraoperative Peritoneal Chemotherapy" (HIPEC.) That general anesthesia will not alter the cardiovascular effects of increased temperature that has been reported in healthy, un-anesthetized humans is the hypothesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperthermia, Cardiac Functional Disturbances During Surgery

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Diagnostic Test

Intervention Name(s)

Transesophageal Echocardiography

Intervention Description

Placement of a transesophageal probe and performance of a diagnostic Transesophageal echocardiography examination.

Primary Outcome Measure Information:

Title

Change in ejection fraction before and after hyperthermia

Time Frame