Adding Vortexing to the Maki Technique Provides no Benefi... | NCT06216184

Studies
Adding Vortexing to the Maki Technique Provides no Benefit for the Diagnosis of Catheter-related Bacteremia

NCT06216184

Sponsor

University Hospital of Canary Islands

Status

Completed

Last Update Posted

Jan 22, 2024Actual

Enrollment

136Actual

Phase

Not provided

Conditions

Catheter-related Bloodstream Infection

Interventions

Vortexing

Countries

Spain

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

Jan 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

Apr 1, 2022Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Jan 9, 2024

First Submission Date that Met QC Criteria

Jan 19, 2024

First Posted Date

Jan 22, 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

Jan 19, 2024

Last Update Posted Date

Jan 22, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leonardo Lorente, Medical assistant, University Hospital of Canary IslandsPrincipal Investigator

Lead Sponsor

University Hospital of Canary IslandsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators wanted to determine whether the combined use of vortexing and Maki techniques provides profitability versus the Maki technique for the diagnosis of catheter tip colonization and catheter-related bloodstream infection

Detailed Description

BACKGROUND A previous study compared vortexing and Maki techniques for the diagnosis of catheter-related bloodstream infection (CRBSI), and concluded that vortexing was not superior to Maki method.

AIM To determine whether the combined use of vortexing and Maki techniques provides profitability versus the Maki technique for the diagnosis of catheter tip colonization (CTC) and CRBSI.

METHODS Observational and prospective study carried out in an Intensive Care Unit. Patients with suspected catheter-related infection (CRI) and with one central venous catheter for at least 7 days were included. The area under the curve (AUC) of the Maki technique, the vortexing technique and the combination of both techniques for the diagnosis of CTC and CRBSI were compared.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

136Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRI		Patients with suspected catheter-related infection (CRI) and with one central venous catheter for at least 7 days were included. The area under the curve (AUC) of the Maki technique, the vortexing technique and the combination of both techniques for the diagnosis of catheter tip colonization (CTC) and diagnosis of catheter-related bloodstream infection (CRBSI) were compared.	Diagnostic Test: Vortexing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vortexing	Diagnostic Test	use combined of vortexing and Maki techniques	CRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnosis of catheter related bloodstream infection	Number of patients with vortexing and/or Maki technique positive	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with suspicion of catheter-related infection (CRI) and with long term CVC (at least 7 days)

Exclusion Criteria:

none

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patient recruitment was performed in the Intensive Care Unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leonardo Lorente		San Cristóbal de La Laguna	Tenerife	38320	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

The study is completed

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided