Impact of Obesity on Clinical Outcomes in Patients Receiving Acyclovir for HSV Encephalitis"

NCT ID: NCT05127395

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2023-04-12

Brief Summary

Multicenter retrospective chart review of patients admitted to any of the six study centers (SSM Health - St. Clare, St. Mary's, Saint Louis University Hospital, St. Anthony's, St. Mary's Madison, Rush University Medical Center, or Methodist Dallas Medical Center) between January 1, 2013 and December 31, 2019 will be conducted. All study centers utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from. Each study center will obtain individual IRB approval prior to data collection. SSM - St. Clare will serve as the lead center for the study with all other centers sending collected and de-identified data to this central site for analysis.

Detailed Description

• Obese - WHO definition: Body Mass Index > 30 kg/m2
• Ideal Body Weight (IBW) (male) - 50.0 kg + 2.3 kg x (patient height in inches, above 60 inches)
• Ideal Body Weight (female) - 45.5 kg + 2.3 kg x (patient height inches, above 60 inches)
• Adjusted Body Weight - IBW + [0.4 x (ABW - IBW)]
• HSV encephalitis - PCR positive for HSV-1 or HSV-2 in CSF during index admission
• Baseline Serum Creatinine (S Cr) - The SCr value obtained before the start of acyclovir therapy on which the dose of acyclovir should be based upon
• Acute Kidney Injury (AKI) - per RIFLE criteria and while receiving acyclovir: SCr doubles or urine output < 0.5 mL/kg/hour for 12 hours
• End-stage renal disease (ESRD) on admission - mention of a diagnosis of ESRD in electronic medical records prior to receipt of acyclovir
• Guideline-approved, weight-based doses - within 10% of 10 mg/kg dose (to account for rounding due to vial size)
• Adequate hydration - IV fluid order (other than KVO [keep vein open]) within 24 hours before acyclovir start AND either IV fluid order (other than KVO) for majority of acyclovir course or IV fluid + oral diet for majority of acyclovir course
• Appropriately renally dose-adjusted doses - Frequency of acyclovir matches package insert recommendations based on creatinine clearance at baseline
• Interacting medications - Mycophenolate, probenecid, zidovudine, tenofovir, valproic acid, phenytoin

Conditions

HSV Encephalitis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

To assess the clinical impact of dosing acyclovir based on IBW or adjBW for HSV encephalitis to definitively guide safe and effective therapy.

The study center utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from. Each study center will obtain individual IRB approval prior to data collection. SSM - St. Clare will serve as the lead center for the study with all other centers sending collected and de-identified data to this central site for analysis.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients Admitted to a SSM Health - St. Clare (STL), St. Mary's (STL), Saint Louis University Hospital (STL), St. Anthony's (OKC), St. Mary's Madison (WIS), Rush University Medical Center (RUMC), or Methodist Dallas Medical Center
• > 18 years old
• Positive cerebrospinal fluid (CSF) PCR for HSV-1 or HSV-2
• BMI > 30 kg/m2
• Received guideline-approved, weight-based doses of IV acyclovir for HSV encephalitis for at least 72 hours during the index admission
• Received appropriately renal dose-adjusted doses of IV acyclovir per package insert recommendations

Exclusion Criteria

• More than one dosing weight strategy utilized for > 24 hours for IV acyclovir dosing during the index admission
• Patients transferred to the hospital already on IV acyclovir for HSV encephalitis
• ESRD on admission
• Concomitant pathogen causing meningitis or encephalitis
• Oral acyclovir used for treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Methodist Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Crotty, PharmD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Methodist Charlton Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

007.PHA.2020.A

Identifier Type: -

Identifier Source: org_study_id