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Impact of Aminoglycosides in Hypotensive Septic Oncology Patients

Evaluating the Impact of Aminoglycosides in Hypotensive Septic Oncology Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05045963
Enrollment
232
Registered
2021-09-16
Start date
2021-01-04
Completion date
2026-02-13
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Septicemia

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.

Interventions

OTHERElectronic Health Record Review

Medical record reviewed

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Time to resolution of hypotensionWithin 7 days from hypotension onsetDefined as a mean arterial pressure \> 65 mmHg not requiring vasopressors and sustained for \>= 24 hours.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJeffrey J Bruno

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026