NCT06209151

Brief Summary

Objectives: To identify the rate and predictors of procedure related infection, the most causative organisms and the effect on ICU stay and in hospital mortality. To show the validity of NEW score in predicting mortality. Methods: Prospective observational study of 1040 patients admitted to the ICU without any signs of infection. All patients were subjected to one or more of the most used procedures in ICU (Intubation \& mechanical ventilation, Central line insertion and Urinary catheterization) for at least 48 hours. Then, they were followed for any signs of infection either clinically or laboratorial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,040

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 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

July 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

December 28, 2023

Last Update Submit

January 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identification of rate and predictors of procedure related infections

    1. Identification of rate and predictors of procedure related infections. 2. Identification of the most causative organisms

    3 months

Secondary Outcomes (1)

  • 1. Identification of the effect of procedure related infections on ICU stay and in hospital mortality.

    3 months

Interventions

Prospective observational study of 1040 patients admitted to the ICU without any signs of infection. All patients were subjected to one or more of the most used procedures in ICU (Intubation \& mechanical ventilation, Central line insertion and Urinary catheterization) for at least 48 hours. Then, they were followed for any signs of infection either clinically or laboratorial.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all ppopulations

You may qualify if:

  • All consecutive adult patients admitted to ICU who had been subjected to the following procedures:
  • Urinary catheterization.
  • Central venous catheter (CVC) insertion.
  • Endotracheal intubation and mechanical ventilation.

You may not qualify if:

  • Patients with evidence of infection prior to ICU admission.
  • Procedures done before ICU admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, 11345, Egypt

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Ahmed Mowafy, MD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of critical care

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 17, 2024

Study Start

July 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations