Heat StrokeNCT01290159
The Development Of A Novel Biomarker For Early Identification Of The Individual's State Of Tolerance To Heat
An observational study of Heat Stroke and Healthy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Today, the level of tolerance to heat is based on physiological strain indices, with no correlates to any relevant biomarker. We hypothesize that oxidative stress (OS) and the formation of reactive oxygen and nitrogen species (ROS, RNS), which are part of the underling pathophysiology related to hyperthermia, can be… Read more about this study
- Who is it for?
- Ages 18 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heat Stroke, Healthy
- What is being tested?
- heat tolerance test (HTT)
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- May 2011to Jul 2013
- Phase
- Observational
- 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 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: young (18-28 years old) post heat stroke subjects, and matched healthy controls
Who may be able to join
- for study group: post heat stroke subjects. for control group: healthy subjects matched by age to study group
Who cannot join
- for control group: any prior heat illness, Diabetes, heart failure, high blood pressure (SBP >140mmHg), any febrile illness within the last two weeks prior to testing.
- for study group: Diabetes, heart failure, high blood pressure (SBP >140mmHg), any febrile illness within the last two weeks prior to testing
Trial locations and contacts
1 site in 1 country.
Israel1 site
Heller Institute of Medical Research, Sheba Medical Center
Tel HaShomer, 52621
About this study
Official title: Preliminary Study of Identifying the Tolerance to Heat by a Novel Biomarker of Oxidative Stress
Today, the level of tolerance to heat is based on physiological strain indices, with no correlates to any relevant biomarker. We hypothesize that oxidative stress (OS) and the formation of reactive oxygen and nitrogen species (ROS, RNS), which are part of the underling pathophysiology related to hyperthermia, can be used to identify tolerance/intolerance to heat. The aim of the present project is to develop a simple assay, based on specific designed sensitive biomarkers of OS that can be detected in a small blood sample, and to possibly correlate each individual's state of tolerance to heat to the level of OS. These biomarkers specially designed and synthesized to form a novel probe (not present as such in biological organs). The method will be based on the incubation of the suggested biomarkers with the patient's blood sample and the measurement of the level and type of oxidative alteration of the markers. For this goal, post heat stroke patients, with different levels of tolerance to heat and subjects during a process of acclimation to heat will be studied. Such a method will add to our ability to better determine the level of tolerance to heat and not rely only on the measurements of temperature and heart rate during an exercise-heat stress.
- Conditions
- Heat Stroke, Healthy
- Being tested
- heat tolerance test (HTT)
- Keywords
- tolerance to heat
- Medical subject headings
- Heat Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heat tolerance test (HTT)Other
Also called heat strain
An exercise-heat test,which consists of 120 min exposure to walking on a treadmill (5km/h; 2% grade) under conditions of 40oC and 50% rh.
| Study group | Role | What they receive |
|---|---|---|
| post heat stroke heat tolerant | Not described Receives: Other: heat tolerance test (HTT) | |
| post heat stroke heat intolerant | Not described Receives: Other: heat tolerance test (HTT) | |
| healthy controls | Not described Receives: Other: heat tolerance test (HTT) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StrokeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Yoram Epstein, Sheba Medical Center
- Investigators
- Yoram Epstein, PhD, Study director, Heller Institute of Medical Research, Sheba Medical Center, Tel HashomerAmit Druyan, MD, Principal investigator, Heller Institute of Medical Research, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290159
- Sponsor's protocol ID
- SHEBA-10-8150-CM-CTIL
- Status last verified
- Dec 2013
- First submitted
- 3 Feb 2011
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of Identifying the Tolerance to Heat by a Novel Biomarker of Oxidative Stress
- ClinicalTrials.gov ID
- NCT01290159
- Acronym / sponsor ID
- SHEBA-10-8150-CM-CTIL
- Conditions
- Heat Stroke, Healthy
- Keywords
- tolerance to heat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Feb 2011 (estimated)
- 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.
Today, the level of tolerance to heat is based on physiological strain indices, with no correlates to any relevant biomarker. We hypothesize that oxidative stress (OS) and the formation of reactive oxygen and nitrogen species (ROS, RNS), which are part of the underling pathophysiology related to hyperthermia, can be used to identify tolerance/intolerance to heat. The aim of the present project is to develop a simple assay, based on specific designed sensitive biomarkers of OS that can be detected in a small blood sample, and to possibly correlate each individual's state of tolerance to heat to the level of OS. These biomarkers specially designed and synthesized to form a novel probe (not present as such in biological organs). The method will be based on the incubation of the suggested biomarkers with the patient's blood sample and the measurement of the level and type of oxidative alteration of the markers. For this goal, post heat stroke patients, with different levels of tolerance to heat and subjects during a process of acclimation to heat will be studied. Such a method will add to our ability to better determine the level of tolerance to heat and not rely only on the measurements of temperature and heart rate during an exercise-heat stress.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| post heat stroke heat tolerant | – | Other: heat tolerance test (HTT) |
| post heat stroke heat intolerant | – | Other: heat tolerance test (HTT) |
| healthy controls | – | Other: heat tolerance test (HTT) |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- young (18-28 years old) post heat stroke subjects, and matched healthy controls
Key inclusion criteria (1 listed)
- for study group: post heat stroke subjects. for control group: healthy subjects matched by age to study group
Key exclusion criteria (2 listed)
- for control group: any prior heat illness, Diabetes, heart failure, high blood pressure (SBP >140mmHg), any febrile illness within the last two weeks prior to testing.
- for study group: Diabetes, heart failure, high blood pressure (SBP >140mmHg), any febrile illness within the last two weeks prior to testing
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 |
|---|---|---|
| heat tolerance test (HTT)Also: heat strainAn exercise-heat test,which consists of 120 min exposure to walking on a treadmill (5km/h; 2% grade) under conditions of 40oC and 50% rh. | Other | healthy controls, post heat stroke heat intolerant, post heat stroke heat tolerant |
Primary outcome
Not reported in the source record.
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 19 Dec 2013.
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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.
Yoram Epstein, PhD study director
Heller Institute of Medical Research, Sheba Medical Center, Tel Hashomer
Amit Druyan, MD principal investigator
Heller Institute of Medical Research, Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heat Stroke and Healthy, run by Sheba Medical Center at 1 site in Israel.
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 2 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 19 Dec 2013. 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 Israel. 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.
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 19 Dec 2013.