Identifying Risk Factors for Gram-negative Resistance for HAP/VAP in the Intensive Care Unit

Completed

• Conditions: Ventilator-associated Pneumonia; Hospital-acquired Pneumonia
• Interventions: Other: Observational

• Registration Number: NCT04700202
• Lead Sponsor: Methodist Health System

Brief Summary

Single center, retrospective chart review. Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP.

Detailed Description

Single center, retrospective chart review. Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP. Patients with respiratory culture data signifying a Gram-negative organism as the cause of HAP/VAP will be analyzed as described below if study inclusion criteria is met. Minimum inhibitory concentration (MIC) data will interpreted per Clinical \& Laboratory Standards Institute (CLSI) standards to determine local patterns of resistance. Multivariable logistic regression will be performed to determine risk factors for piperacillin-tazobactam, cefepime or meropenem resistant Gram-negative isolates. Project target date of completion and close-out is May 2021.

Study Timeline

• Study Start: 2020-06-30
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• ICU, Neuro critical care unit admission
• Diagnosis of HAP or VAP
• Respiratory culture positive for Gram-negative organism

Exclusion Criteria

• ICU length of stay <48 hours prior to HAP/VAP
• Culture or MIC data unavailable
• Pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective Cohort	Observational	Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP.

Primary Outcome Measures

Name	Time	Method
Rate of Gram-negative isolate resistance to piperacillin-tazobactam, cefepime, meropenem	April 2017 - May 2020	Percentage

Secondary Outcome Measures

Name	Time	Method
duration of mechanical ventilation	April 2017 - May 2020	number of days
Rate of susceptibility to non-beta lactam antipseudomonal agents	April 2017 - May 2020	Percentage
need for mechanical ventilation	April 2017 - May 2020	Percentage
development of septic shock	April 2017 - May 2020	Percentage
ICU length of stay	April 2017 - May 2020	number of days
hospital length of stay	April 2017 - May 2020	number of days
in-hospital mortality	April 2017 - May 2020	Percentage

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States