Evaluation of Lab Exams Accuracy in the Intensive Care Unit | NCT06622096

Studies
Evaluation of Lab Exams Accuracy in the Intensive Care Unit

NCT06622096

Sponsor

Mongi Slim Hospital

Status

Completed

Last Update Posted

Oct 1, 2024Actual

Enrollment

63Actual

Phase

Not provided

Conditions

Laboratory Testing
Intensive Care Unit ICU
Accuracy

Interventions

Evaluation of laboratory exams prescription

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Aug 1, 2024Actual

Completion Date

Sep 1, 2024Actual

First Submitted Date

Sep 25, 2024

First Submission Date that Met QC Criteria

Sep 28, 2024

First Posted Date

Oct 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2024

Last Update Posted Date

Oct 1, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mhamed Sami Mebazaa, Professor, head of the ICU department, Mongi Slim HospitalPrincipal Investigator

Lead Sponsor

Mongi Slim HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Laboratory exams prescription for ICU patients was evaluated daily and their accuracy was determined according to locally implemented prescription protocol and to their abnormalities and the impact on further therapeutics.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

90 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICU patients with a predicted length of stay > 24 hours			Diagnostic Test: Evaluation of laboratory exams prescription

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evaluation of laboratory exams prescription	Diagnostic Test	Evaluation of laboratory exams prescription	ICU patients with a predicted length of stay > 24 hours

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood loss due to laboratory tests	evolution of hemoglobin levels before and after laboratory tests	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients transferred from other ICUs
Currently unavailable laboratory tests

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All adult patients admitted in the ICU for more than 24 hours

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mongi Slim University Hospital		Tunis	Tunis Governorate	2046	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided