NCT04792736

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

March 8, 2021

Last Update Submit

March 8, 2021

Conditions

Mortality

Keywords

LactatesPrognosisintensive care units

Outcome Measures

Primary Outcomes (1)

  • ICU Mortality

    Mortality at Day 28

    28 days after ICU admission

Study Arms (2)

Survivors

Patients discharged alive from intensive care unit

Diagnostic Test: Blood lactate level

non survivors

Patients who succumbed during their ICU stay

Diagnostic Test: Blood lactate level

Interventions

Blood lactate levelDIAGNOSTIC_TEST

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

Survivorsnon survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All adults admissions in ICU with a predicted length of stay \> 24 hours

You may not qualify if:

  • Patients who died during the first 24 hours after ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mongi Slim University Hospital

La Marsa, Tunis Governorate, 2046, Tunisia

Location

Mongi Slim Hospital

Tunis, 2046, Tunisia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor head of ICU department

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

June 1, 2019

Primary Completion

June 30, 2020

Study Completion

July 31, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)