Hematopoietic and Lymphoid Cell NeoplasmNCT05045963
Impact of Aminoglycosides in Hypotensive Septic Oncology Patients
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Septicemia
- What is being tested?
- Electronic Health Record Review
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 13 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Impact of Aminoglycosides in Hypotensive Septic Oncology Patients
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the impact of beta-lactam (BL) + aminoglycoside (AG) combination therapy in hypotensive septic oncology patients.
OUTLINE:
Patients' medical charts are reviewed retrospectively.
- Being tested
- Electronic Health Record Review
- Medical subject headings
- Hematologic Neoplasms, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Medical record reviewed
| Study group | Role | What they receive |
|---|---|---|
| Observational (medical record review) | Patients' medical charts are reviewed retrospectively. Receives: Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of hypotension
Defined as a mean arterial pressure > 65 mmHg not requiring vasopressors and sustained for >= 24 hours.
Measured: Within 7 days from hypotension onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start4 Jan 2021
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey J Bruno, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045963
- Sponsor's protocol ID
- 2020-0999
- Other IDs
- NCI-2021-01105, 2020-0999
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2021
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Aminoglycosides in Hypotensive Septic Oncology Patients
- ClinicalTrials.gov ID
- NCT05045963
- Acronym / sponsor ID
- 2020-0999
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the impact of beta-lactam (BL) + aminoglycoside (AG) combination therapy in hypotensive septic oncology patients.
OUTLINE:
Patients' medical charts are reviewed retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (medical record review) | – | Other: Electronic Health Record ReviewPatients' medical charts are reviewed retrospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewMedical record reviewed | Other | Observational (medical record review) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- University of Texas MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J Bruno principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of hypotension (time frame: Within 7 days from hypotension onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.