Prognostic Value of Lactates in ICU

March 8, 2021 updated by: Mhamed Sami Mebazaa, Mongi Slim Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

135

Contacts and Locations

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

Study Locations

  • Tunisia
      • Tunis, Tunisia, 2046
        • Mongi Slim Hospital
    • Tunis
      • La Marsa, Tunis, Tunisia, 2046
        • Mongi Slim University Hospital

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients admitted in ICU after major trauma or surgery or for medical reasons.

Description

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 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
Survivors
Patients discharged alive from intensive care unit
Diagnostic test: Blood lactate level
Blood lactate level measured at admission H0, every 6 hours during the first 24 h and at H48
non survivors
Patients who succumbed during their ICU stay
Diagnostic test: Blood lactate level
Blood lactate level measured at admission H0, every 6 hours during the first 24 h and at H48

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Mortality
Time Frame: 28 days after ICU admission
Mortality at Day 28
28 days after ICU admission

Collaborators and Investigators

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

Sponsor

Mongi Slim Hospital

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 1, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Lactates ICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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