Trace ElementsNCT04935385
Trace Element During Anesthesia Insertion and Surgery-
An observational study of Trace Elements, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Trace elements are micronutrients that are of vital important importance to human health and are involved in the process of many key human functions including the immune response, antioxidant defense and wound healing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trace Elements
- What is being tested?
- Collecting blood specimens
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Jun 2021to 1 Jun 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18 and above undergoing elective surgeries (including general surgery, neurosurgery, ear nose and throat surgeries, cardiac surgery, orthopedic surgeries, vascular surgeries and urological surgeries) at Rabin Medical Center under general anesthesia will be eligible for participation.
Who may be able to join
- Patients 18 and above
- Patients undergoing elective surgeries (as detailed above) under general anesthesia.
- Patients who can read and write Hebrew
Who cannot join
- Emergency surgery
- Regional anesthesia only
Trial locations and contacts
1 site in 1 country.
Atara Davis contact
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center/Beilinson Campus
Petah Tikva, 49100
Binyamin Zerbi, M.D.
Michal Y Livne, M.D
About this study
Official title: Monitoring Trace Element During Anesthesia Insertion and Surgery- A Prospective, Observational, Cohort Trial
Trace elements are micronutrients that are of vital important importance to human health and are involved in the process of many key human functions including the immune response, antioxidant defense and wound healing. Deficiency in a single element can manifest with multiple systems and can have significant organ impact.
Research has shown correlation between deficiencies in trace elements and increased risk for infections, sepsis, multi organ failure and mortality. However relatively few studies examined the impact of perioperative changes in trace elements and patients' postoperative outcomes.
Read more
In this prospective observational cohort study, we aim to examine the impact of perioperative changes in trace elements on postoperative outcomes, morbidity and mortality.
This study will include patients aged 18 and above undergoing elective surgeries under general anesthesia at Rabin Medical Center. In the operating room blood samples will be collected from all study participants in the beginning of surgery and at the end of surgery.
Collected samples will be sent for analysis of periodic table elements to assess the perioperative period changes in trace elements measured in whole blood. Participants intraoperative and postoperative data will be collected. All postoperative complications will be documented. Perioperative changes will be correlated with participants' postoperative outcomes using computer analytical correlations.
- Conditions
- Trace Elements
- Being tested
- Collecting blood specimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting blood specimensOther
Blood samples will be collected from all study participants at different required timelines
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Patients aged 18 and above undergoing elective surgeries (including general surgery, neurosurgery, ear nose and throat surgeries, cardiac surgery, orthopedic surgeries, vascular surgeries and urological surgeries) at Rabin Medical Center under general anesthesia Receives: Other: Collecting blood specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
periodic trace elements measured in whole blood before and after surgery under general anesthesia.
Measured: 24 hours from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start13 Jun 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trace ElementsStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935385
- Sponsor's protocol ID
- 0159-21
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Trace Element During Anesthesia Insertion and Surgery- A Prospective, Observational, Cohort Trial
- ClinicalTrials.gov ID
- NCT04935385
- Acronym / sponsor ID
- 0159-21
- Conditions
- Trace Elements
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 13 Jun 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 23 Jun 2021 (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.
Trace elements are micronutrients that are of vital important importance to human health and are involved in the process of many key human functions including the immune response, antioxidant defense and wound healing. Deficiency in a single element can manifest with multiple systems and can have significant organ impact.
Research has shown correlation between deficiencies in trace elements and increased risk for infections, sepsis, multi organ failure and mortality. However relatively few studies examined the impact of perioperative changes in trace elements and patients' postoperative outcomes.
In this prospective observational cohort study, we aim to examine the impact of perioperative changes in trace elements on postoperative outcomes, morbidity and mortality.
This study will include patients aged 18 and above undergoing elective surgeries under general anesthesia at Rabin Medical Center. In the operating room blood samples will be collected from all study participants in the beginning of surgery and at the end of surgery.
Collected samples will be sent for analysis of periodic table elements to assess the perioperative period changes in trace elements measured in whole blood. Participants intraoperative and postoperative data will be collected. All postoperative complications will be documented. Perioperative changes will be correlated with participants' postoperative outcomes using computer analytical correlations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Other: Collecting blood specimensPatients aged 18 and above undergoing elective surgeries (including general surgery, neurosurgery, ear nose and throat surgeries, cardiac surgery, orthopedic surgeries, vascular surgeries and urological surgeries) at Rabin Medical Center under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 and above undergoing elective surgeries (including general surgery, neurosurgery, ear nose and throat surgeries, cardiac surgery, orthopedic surgeries, vascular surgeries and urological surgeries) at Rabin Medical Center under general anesthesia will be eligible for participation.
Key inclusion criteria (3 listed)
- Patients 18 and above
- Patients undergoing elective surgeries (as detailed above) under general anesthesia.
- Patients who can read and write Hebrew
Key exclusion criteria (2 listed)
- Emergency surgery
- Regional anesthesia only
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 |
|---|---|---|
| Collecting blood specimensBlood samples will be collected from all study participants at different required timelines | Other | Study Cohort |
Primary outcome
periodic trace elements measured in whole blood before and after surgery under general anesthesia.
Time frame: 24 hours from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Atara Davis contact
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 Trace Elements, run by Rabin 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 3 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: status not confirmed, as of the sponsor's last update on 3 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonid Eidelman (039376850, leidelman@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periodic trace elements measured in whole blood before and after surgery under general anesthesia. (time frame: 24 hours from surgery). 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 3 May 2022.