Impact of Aminoglycosides in Hypotensive Septic Oncology Patients

NCT05045963 | Completed

• 2 other identifiers: 2020-0999NCI-2021-01105
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Septicemia

Outcome Measures

Primary Outcomes (1)

• Time to resolution of hypotension

  Defined as a mean arterial pressure \> 65 mmHg not requiring vasopressors and sustained for \>= 24 hours.

  Within 7 days from hypotension onset

Study Arms (1)

Observational (medical record review)

Patients' medical charts are reviewed retrospectively.

Other: Electronic Health Record Review

Interventions

Electronic Health Record Review OTHER

Medical record reviewed

Observational (medical record review)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Oncology patients with sepsis and hypotension treated at The University of Texas MD Anderson Cancer Center from January 1, 2019 to December 31, 2019

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms; Sepsis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey J Bruno

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: September 16, 2021
• Study Start: January 4, 2021
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)