Effect of Heat Stress on Global LV Function in Anesthetized Humans

NCT04553900 | Completed

• 1 other identifier: 171159
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperthermia; Cardiac Functional Disturbances During Surgery

Outcome Measures

Primary Outcomes (1)

• Change in ejection fraction before and after hyperthermia

  Approximately 6 hours from prior to hyperthermia to during hyperthermia.

Secondary Outcomes (3)

• 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.

Other Outcomes (2)

• heart rate before and during hyperthermia

  Approximately 6 hours from prior to hyperthermia to during hyperthermia.

• mean arterial pressure before and during hyperthermia

  Approximately 6 hours from prior to hyperthermia to during hyperthermia.

Interventions

Transesophageal Echocardiography DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any patient presenting for hyperthermic intraperitoneal chemotherapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Hyperthermia

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Edward O O'Brien, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 18, 2020
• Study Start: June 9, 2017
• Primary Completion: December 6, 2019
• Study Completion: December 6, 2019
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)