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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04553900
Other study ID # 171159
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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