Effect of Heat Stress on Global LV Function in Anesthetized Humans

Hyperthermia Clinical Trial

Official title:

Effect of Heat Stress on Global LV Function in Anesthetized Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553900
• Other study ID #: 171159
• Status: Completed
• Phase: N/A
• Start date: June 9, 2017
• Est. completion date: December 6, 2019

Study information

• Verified date: September 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 6, 2019
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Functional Disturbances During Surgery
• Fever
• Hyperthermia

Intervention

Diagnostic Test:
• Transesophageal Echocardiography
Placement of a transesophageal probe and performance of a diagnostic Transesophageal echocardiography examination.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	heart rate before and during hyperthermia		Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Other	mean arterial pressure before and during hyperthermia		Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Primary	Change in ejection fraction before and after hyperthermia		Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Secondary	Transmitral inflow velocities before and after hyperthermia		Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Secondary	Pulmonary venous inflow velocities before and during hyperthermia		Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Secondary	Mitral annular tissue doppler velocities before and during hyperthermia		Approximately 6 hours from prior to hyperthermia to during hyperthermia.