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Impact of Aminoglycosides in Hypotensive Septic Oncology Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05045963
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Septicemia Other: Electronic Health Record Review

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.

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Study Type : Observational
Estimated Enrollment : 319 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluating the Impact of Aminoglycosides in Hypotensive Septic Oncology Patients
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : July 2, 2022
Estimated Study Completion Date : July 2, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational (medical record review)
Patients' medical charts are reviewed retrospectively.
Other: Electronic Health Record Review
Medical record reviewed




Primary Outcome Measures :
  1. Time to resolution of hypotension [ Time Frame: Within 7 days from hypotension onset ]
    Defined as a mean arterial pressure > 65 mmHg not requiring vasopressors and sustained for >= 24 hours.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05045963


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jeffrey J. Bruno    713-792-0251    JJbruno@mdanderson.org   
Principal Investigator: Jeffrey J. Bruno         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Jeffrey J Bruno M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05045963    
Other Study ID Numbers: 2020-0999
NCI-2021-01105 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0999 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sepsis
Neoplasms
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes