Trace Element During Anesthesia Insertion and Surgery-

May 2, 2022 updated by: Rabin Medical Center

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Petach Tikva, Israel, 49100
        • Recruiting
        • Rabin Medical Center/Beilinson Campus
        • Sub-Investigator:
          • Michal Y Livne, M.D

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patients 18 and above
  • Patients undergoing elective surgeries (as detailed above) under general anesthesia.
  • Patients who can read and write Hebrew

Exclusion Criteria:

  1. Emergency surgery
  2. Regional anesthesia only

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Collecting blood specimens
Blood samples will be collected from all study participants at different required timelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
periodic trace elements measured in whole blood before and after surgery under general anesthesia.
Time Frame: 24 hours from surgery
24 hours from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

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 13, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (ACTUAL)

June 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 0159-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Trace Elements

Clinical Trials on Collecting blood specimens

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe