HyperthermiaNCT04553900
Effect of Heat Stress on Global LV Function in Anesthetized Humans
A study testing Transesophageal Echocardiography in people with Hyperthermia and Cardiac Functional Disturbances During Surgery, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperthermia, Cardiac Functional Disturbances During Surgery
- What is being tested?
- Transesophageal Echocardiography
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2017to 6 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any patient presenting for hyperthermic intraperitoneal chemotherapy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
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.
- Being tested
- Transesophageal Echocardiography
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal EchocardiographyDiagnostic test
Placement of a transesophageal probe and performance of a diagnostic Transesophageal echocardiography examination.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ejection fraction before and after hyperthermia
Measured: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Secondary outcomes (3)
Transmitral inflow velocities before and after hyperthermia
Measured: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Pulmonary venous inflow velocities before and during hyperthermia
Measured: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Mitral annular tissue doppler velocities before and during hyperthermia
Measured: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start9 Jun 2017
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward O'Brien, University of California, San Diego
- Investigators
- Edward O O'Brien, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553900
- Sponsor's protocol ID
- 171159
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heat Stress on Global LV Function in Anesthetized Humans
- ClinicalTrials.gov ID
- NCT04553900
- Acronym / sponsor ID
- 171159
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any patient presenting for hyperthermic intraperitoneal chemotherapy.
Key exclusion criteria (6 listed)
- Subjects less than 18 years old.
- pregnant women
- prisoners,
- institutionalized individuals
- Any patient with known contraindication to Transesophageal echocardiography.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal EchocardiographyPlacement of a transesophageal probe and performance of a diagnostic Transesophageal echocardiography examination. | Diagnostic test | – |
Primary outcome
Change in ejection fraction before and after hyperthermia
Time frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
3 secondary outcomes
Transmitral inflow velocities before and after hyperthermia
Time frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Pulmonary venous inflow velocities before and during hyperthermia
Time frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Mitral annular tissue doppler velocities before and during hyperthermia
Time frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward O O'Brien, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transesophageal Echocardiography in people with Hyperthermia and Cardiac Functional Disturbances During Surgery, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ejection fraction before and after hyperthermia (time frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.