- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04553900
Effect of Heat Stress on Global LV Function in Anesthetized Humans
September 17, 2020 updated by: Edward O'Brien, University of California, San Diego
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92093
- University of California, San Diego
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in ejection fraction before and after hyperthermia
Time Frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
|
Approximately 6 hours from prior to hyperthermia to during hyperthermia.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Transmitral inflow velocities before and after hyperthermia
Time Frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
|
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.
|
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.
|
Approximately 6 hours from prior to hyperthermia to during hyperthermia.
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
heart rate before and during hyperthermia
Time Frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
|
Approximately 6 hours from prior to hyperthermia to during hyperthermia.
|
mean arterial pressure before and during hyperthermia
Time Frame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
|
Approximately 6 hours from prior to hyperthermia to during hyperthermia.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Edward O O'Brien, MD, University of California, San Diego
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2017
Primary Completion (Actual)
December 6, 2019
Study Completion (Actual)
December 6, 2019
Study Registration Dates
First Submitted
September 11, 2020
First Submitted That Met QC Criteria
September 11, 2020
First Posted (Actual)
September 18, 2020
Study Record Updates
Last Update Posted (Actual)
September 21, 2020
Last Update Submitted That Met QC Criteria
September 17, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 171159
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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