Prognostic Value of Lactates in ICU

Sponsor

Mongi Slim Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04792736

Collaborator

(none)

135

Enrollment

Locations

Actual Duration (Months)

67.5

Patients Per Site

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mortality	Diagnostic Test: Blood lactate level

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

Study Type:

Observational

Actual Enrollment :

135 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prognostic Value of Lactates in Predicting Intensive Care Unit Mortality

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jul 31, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

ICU Mortality [28 days after ICU admission]
Mortality at Day 28

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mongi Slim University Hospital	La Marsa	Tunis	Tunisia	2046
2	Mongi Slim Hospital	Tunis		Tunisia	2046

Sponsors and Collaborators

Mongi Slim Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mhamed Sami Mebazaa, Professor head of ICU department, Mongi Slim Hospital

ClinicalTrials.gov Identifier:

NCT04792736

Other Study ID Numbers:

Lactates ICU

First Posted:

Mar 11, 2021

Last Update Posted:

Mar 11, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mhamed Sami Mebazaa, Professor head of ICU department, Mongi Slim Hospital

Lactates

Prognosis

intensive care units

Study Results

No Results Posted as of Mar 11, 2021