Effect of Heat Stress on Global LV Function in Anesthetized Humans

Not Applicable

Completed

• Conditions: Hyperthermia; Cardiac Functional Disturbances During Surgery

• Registration Number: NCT04553900
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-09
• Primary Completion: 2019-12-06
• Study Completion: 2019-12-06
• Status Verified: 2020-09
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-11
• Last Update Submitted: 2020-09-17
• Study First Posted: 2020-09-18
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in ejection fraction before and after hyperthermia	Approximately 6 hours from prior to hyperthermia to during hyperthermia.

Secondary Outcome Measures

Name	Time	Method
Transmitral inflow velocities before and after hyperthermia	Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Pulmonary venous inflow velocities before and during hyperthermia	Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Mitral annular tissue doppler velocities before and during hyperthermia	Approximately 6 hours from prior to hyperthermia to during hyperthermia.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States