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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04792736
Other study ID # Lactates ICU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date July 31, 2020

Study information

Verified date March 2021
Source Mongi Slim Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

he aim of this prospective, analytic trial was to evaluate the accuracy of blood lactates levels in predicting mortality in ICU patients.


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.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date July 31, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All adults admissions in ICU with a predicted length of stay > 24 hours Exclusion Criteria: - Patients who died during the first 24 hours after ICU admission

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood lactate level
Blood lactate level measured at admission H0, every 6 hours during the first 24 h and at H48

Locations

Country Name City State
Tunisia Mongi Slim University Hospital La Marsa Tunis
Tunisia Mongi Slim Hospital Tunis

Sponsors (1)

Lead Sponsor Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary ICU Mortality Mortality at Day 28 28 days after ICU admission
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