Impact of Aminoglycosides in Hypotensive Septic Oncology Patients

Recruiting

• Conditions: Septicemia; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Interventions: Other: Electronic Health Record Review

• Registration Number: NCT05045963
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This study evaluates the impact of aminoglycosides in hypotensive septic oncologic patients. In the oncologic patient population, sepsis is a major health concern due to high mortality rates and healthcare costs. Prior research shows aminoglycosides antibiotics are frequently used to treat sepsis, but their clinical impact in hypotensive oncology patients upon the progression of sepsis is not known.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the impact of beta-lactam (BL) + aminoglycoside (AG) combination therapy in hypotensive septic oncology patients.

OUTLINE:

Patients' medical charts are reviewed retrospectively.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-04
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-07-02
• Study Completion: 2025-07-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 319

Inclusion Criteria

• Adult patients (age >= 18 years) with a diagnosis of sepsis during the index hospital admission identified by International classification of diseases (ICD)-10 codes (as specified below) receiving BL antibiotics within 6 hours prior to or following the onset of hypotension
• To be included in the AG group, patients must have received at least 1 dose of intravenous (IV) tobramycin or amikacin in addition to the BL therapy within the above time period

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Exclusion Criteria

• Age < 18 years
• Receipt of IV AG outside of the above time frame in the AG group or receipt of IV AG within 48 hours prior to or following the onset of hypotension in the BL backbone group
• Pregnancy
• Patients not receiving therapy with BL antibiotics

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (medical record review)	Electronic Health Record Review	Patients' medical charts are reviewed retrospectively.

Primary Outcome Measures

Name	Time	Method
Time to resolution of hypotension	Within 7 days from hypotension onset	Defined as a mean arterial pressure \> 65 mmHg not requiring vasopressors and sustained for \>= 24 hours.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States