NCT06216184

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

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

April 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 9, 2024

Last Update Submit

January 19, 2024

Conditions

Catheter-related Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

  • diagnosis of catheter related bloodstream infection

    Number of patients with vortexing and/or Maki technique positive

    6 months

Study Arms (1)

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

VortexingDIAGNOSTIC_TEST

use combined of vortexing and Maki techniques

CRI

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient recruitment was performed in the Intensive Care Unit

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leonardo Lorente

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical assistant

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 22, 2024

Study Start

April 1, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

The study is completed

Locations

ES(1)