NCT06622096

Brief Summary

prospective, observational descriptive study assessing the accuracy of laboratory exams in the ICU.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 25, 2024

Last Update Submit

September 28, 2024

Conditions

Laboratory TestingIntensive Care Unit ICUAccuracy

Outcome Measures

Primary Outcomes (1)

  • Blood loss due to laboratory tests

    evolution of hemoglobin levels before and after laboratory tests

    7 days

Study Arms (1)

ICU patients with a predicted length of stay > 24 hours

Diagnostic Test: Evaluation of laboratory exams prescription

Interventions

Evaluation of laboratory exams prescriptionDIAGNOSTIC_TEST

Evaluation of laboratory exams prescription

ICU patients with a predicted length of stay > 24 hours

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 the ICU for more than 24 hours

You may qualify if:

  • All adults ICU patients with a length of stay\>24 hours

You may not qualify if:

  • Patients transferred from other ICUs
  • Currently unavailable laboratory tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongi Slim University Hospital

Tunis, Tunis Governorate, 2046, Tunisia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, head of the ICU department

Study Record Dates

First Submitted

September 25, 2024

First Posted

October 1, 2024

Study Start

September 1, 2023

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)