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CompletedNCT04553900Updated Sep 21, 2020

Effect of Heat Stress on Global LV Function in Anesthetized Humans

An interventional study of Transesophageal Echocardiography in Hyperthermia and Cardiac Functional Disturbances During Surgery, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-21.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jun 2017, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Hyperthermia
  • Cardiac Functional Disturbances During Surgery

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03

In context

Hyperthermia

478 studies on the registry are indexed under Hyperthermia; 92 are open to participants now.

This study's enrollment of 28 is below the median of 60 across 365 interventional studies indexed under Hyperthermia.

Browse Hyperthermia studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • any patient presenting for hyperthermic intraperitoneal chemotherapy.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Interventions

  • Diagnostic testTransesophageal Echocardiography

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

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What researchers measure

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.

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Study locations

1 site
  • University of California, San Diego
    La Jolla, California 92093, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04553900
Lead sponsor
University of California, San Diego
Responsible party
Edward O'Brien (Associate Professor of Anesthesiology, University of California, San Diego) — Principal investigator
First posted
Sep 18, 2020
Start date
Jun 9, 2017
Primary completion
Dec 6, 2019
Completion
Dec 6, 2019
Last update
Sep 21, 2020

Study contacts

Edward O O'Brien, MD
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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