MortalityNCT04792736
Prognostic Value of Lactates in ICU
An observational study of Mortality, run by Mongi Slim Hospital at 2 sites in Tunisia.
Trial summary
he aim of this prospective, analytic trial was to evaluate the accuracy of blood lactates levels in predicting mortality in ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mortality
- What is being tested?
- Blood lactate level
- How many people
- 135 participants
- Where
- 2 sitesTunisia
- Study dates
- 1 Jun 2019to 31 Jul 2020
- 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 ICU after major trauma or surgery or for medical reasons.
Who may be able to join
- All adults admissions in ICU with a predicted length of stay > 24 hours
Who cannot join
- Patients who died during the first 24 hours after ICU admission
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Mongi Slim University Hospital
La Marsa, Tunis Governorate, 2046
Mongi Slim Hospital
Tunis, 2046
About this study
Official title: Prognostic Value of Lactates in Predicting Intensive Care Unit Mortality
he aim of this prospective, analytic trial was to evaluate the accuracy of blood lactates levels in predicting mortality in ICU patients.
Read the detailed description
In this study, conducted over o 12 months period, arterial blood lactates levels were measured in ICU patients at admission (H0), every 6 hours during the first day and and H48.
This trial included traumatic, medical and surgical patients requiring ICU stay for a predictive period > to 24 hours.
Blood lactates were evaluated as a prognostic parameter in predicting ICU mortality and compared to classic prognostic scores such as: SOFA score, IGS II and APACHE II.
The primary end point was ICU mortality.
- Conditions
- Mortality
- Being tested
- Blood lactate level
- Keywords
- Lactates, Prognosis, intensive care units
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood lactate levelDiagnostic test
Blood lactate level measured at admission H0, every 6 hours during the first 24 h and at H48
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Patients discharged alive from intensive care unit Receives: Diagnostic Test: Blood lactate level | |
| non survivors | Patients who succumbed during their ICU stay Receives: Diagnostic Test: Blood lactate level |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
Mortality at Day 28
Measured: 28 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Jun 2019
- Primary completion30 Jun 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies 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
- 135 participants (actual)
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
- NCT04792736
- Sponsor's protocol ID
- Lactates ICU
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- 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 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Lactates in Predicting Intensive Care Unit Mortality
- ClinicalTrials.gov ID
- NCT04792736
- Acronym / sponsor ID
- Lactates ICU
- Conditions
- Mortality
- Keywords
- Lactates, Prognosis, intensive care units
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 11 Mar 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.
he aim of this prospective, analytic trial was to evaluate the accuracy of blood lactates levels in predicting mortality in ICU patients.
Detailed description
In this study, conducted over o 12 months period, arterial blood lactates levels were measured in ICU patients at admission (H0), every 6 hours during the first day and and H48.
This trial included traumatic, medical and surgical patients requiring ICU stay for a predictive period > to 24 hours.
Blood lactates were evaluated as a prognostic parameter in predicting ICU mortality and compared to classic prognostic scores such as: SOFA score, IGS II and APACHE II.
The primary end point was ICU mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Diagnostic Test: Blood lactate levelPatients discharged alive from intensive care unit |
| non survivors | – | Diagnostic Test: Blood lactate levelPatients who succumbed during their ICU stay |
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 ICU after major trauma or surgery or for medical reasons.
Key inclusion criteria (1 listed)
- All adults admissions in ICU with a predicted length of stay > 24 hours
Key exclusion criteria (1 listed)
- Patients who died during the first 24 hours after ICU admission
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 |
|---|---|---|
| Blood lactate levelBlood lactate level measured at admission H0, every 6 hours during the first 24 h and at H48 | Diagnostic test | Survivors, non survivors |
Primary outcome
ICU Mortality
Time frame: 28 days after ICU admission
Mortality at Day 28
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 11 Mar 2021.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mortality, run by Mongi Slim Hospital at 2 sites 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 1 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
ICU Mortality (time frame: 28 days after ICU admission). 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 11 Mar 2021.