Laboratory TestingNCT06622096
Evaluation of Lab Exams Accuracy in the Intensive Care Unit
An observational study of Laboratory Testing and Intensive Care Unit ICU, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
prospective, observational descriptive study assessing the accuracy of laboratory exams in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laboratory Testing, Intensive Care Unit ICU, Accuracy
- What is being tested?
- Evaluation of laboratory exams prescription
- How many people
- 63 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Sep 2023to 1 Sep 2024
- How long will I take part?
- 90 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients admitted in the ICU for more than 24 hours
Who may be able to join
- All adults ICU patients with a length of stay\>24 hours
Who cannot join
- Patients transferred from other ICUs
- Currently unavailable laboratory tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rationalization of Laboratory Tests in the ICU: Current State of Play
prospective, observational descriptive study assessing the accuracy of laboratory exams in the ICU.
Read the detailed description
Laboratory exams prescription for ICU patients was evaluated daily and their accuracy was determined according to locally implemented prescription protocol and to their abnormalities and the impact on further therapeutics.
- Conditions
- Laboratory Testing, Intensive Care Unit ICU, Accuracy
- Being tested
- Evaluation of laboratory exams prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of laboratory exams prescriptionDiagnostic test
Evaluation of laboratory exams prescription
| Study group | Role | What they receive |
|---|---|---|
| ICU patients with a predicted length of stay > 24 hours | Not described Receives: Diagnostic Test: Evaluation of laboratory exams prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss due to laboratory tests
evolution of hemoglobin levels before and after laboratory tests
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Sep 2023
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laboratory TestingStudies 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
- 63 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622096
- Sponsor's protocol ID
- Lab exams in the ICU
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationalization of Laboratory Tests in the ICU: Current State of Play
- ClinicalTrials.gov ID
- NCT06622096
- Acronym / sponsor ID
- Lab exams in the ICU
- Conditions
- Laboratory Testing, Intensive Care Unit ICU, Accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 1 Oct 2024 (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.
prospective, observational descriptive study assessing the accuracy of laboratory exams in the ICU.
Detailed description
Laboratory exams prescription for ICU patients was evaluated daily and their accuracy was determined according to locally implemented prescription protocol and to their abnormalities and the impact on further therapeutics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients with a predicted length of stay > 24 hours | – | Diagnostic Test: Evaluation of laboratory exams prescription |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted in the ICU for more than 24 hours
Key inclusion criteria (1 listed)
- All adults ICU patients with a length of stay\>24 hours
Key exclusion criteria (2 listed)
- Patients transferred from other ICUs
- Currently unavailable laboratory tests
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 |
|---|---|---|
| Evaluation of laboratory exams prescriptionEvaluation of laboratory exams prescription | Diagnostic test | ICU patients with a predicted length of stay > 24 hours |
Primary outcome
Blood loss due to laboratory tests
Time frame: 7 days
evolution of hemoglobin levels before and after laboratory tests
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 1 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Laboratory Testing and Intensive Care Unit ICU, run by Mongi Slim Hospital at 1 site in Tunisia.
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 1 Oct 2024. 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 Tunisia. 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?
Blood loss due to laboratory tests (time frame: 7 days). 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 1 Oct 2024.