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OpenTrials
Completed

NCT Number: NCT04553900

Effect of Heat Stress on Global LV Function in Anesthetized Humans

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.

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Key information

Conditions

Hyperthermia Body Temperature Changes Cardiac Functional Disturbances During Surgery Heat Stress Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transesophageal Echocardiography

Diagnostic Test

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

Primary outcomes

  1. Change in ejection fraction before and after hyperthermia

    Time frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.

Secondary outcomes

  1. Transmitral inflow velocities before and after hyperthermia

    Time frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.

  2. Pulmonary venous inflow velocities before and during hyperthermia

    Time frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.

  3. Mitral annular tissue doppler velocities before and during hyperthermia

    Time frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.

Other outcomes

  1. heart rate before and during hyperthermia

    Time frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.

  2. mean arterial pressure before and during hyperthermia

    Time frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2020
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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