NephrotoxicityNCT01216540
Vancomycin-Associated Nephrotoxicity
An observational study of Nephrotoxicity, run by University at Buffalo at 1 site in United States.
Trial summary
The primary goal of this study is to determine if there is an association between greater exposure to vancomycin and the development of nephrotoxicity. The secondary goal is to estimate the costs to the hospital associated with these nephrotoxic events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotoxicity
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Apr 2011
- 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: A simple random sample of 400 patients treated with greater than 48 hours of intravenous vancomycin exposure during hospitalization during the time period from July 1, 2009 through June 30, 2010
Who may be able to join
- 18 years or older at time of hospital admission
- Had an absolute neutrophil count of ≥ 1000 cells/mm^3
- Received > 48 hours of intravenous vancomycin therapy
- Had one or more vancomycin trough levels reported within the 96 hours after therapy initiation
- Had a baseline serum creatinine level of < 2.0 mg/dL and baseline creatinine clearance level of ≥ 30 mL/min
Who cannot join
- Previous diagnosis of cystic fibrosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Occurrence and Economic Impact of Nephrotoxicity Associated With Vancomycin Exposure
The primary goal of this study is to determine if there is an association between greater exposure to vancomycin and the development of nephrotoxicity. The secondary goal is to estimate the costs to the hospital associated with these nephrotoxic events.
- Conditions
- Nephrotoxicity
- Keywords
- vancomycin, nephrotoxicity, length of stay, costs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving vancomycin | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to nephrotoxicity
Measured: within 72 hours post completion of vancomycin therapy
Secondary outcomes (2)
Hospital costs
Measured: until discharge
Length of stay
Measured: until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrotoxicityStudies of the same condition, open and under way.
- 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
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Principal investigator, Vanessa Stevens, University at Buffalo
- Investigators
- Jack Brown, PharmD, Principal investigator, State University of New York at BuffaloVanessa Stevens, PhD, Principal investigator, Internal Medicine, Division of Epidemiology, University of Utah School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216540
- Sponsor's protocol ID
- IIS-000184
- Status last verified
- Sep 2022
- First submitted
- 6 Oct 2010
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occurrence and Economic Impact of Nephrotoxicity Associated With Vancomycin Exposure
- ClinicalTrials.gov ID
- NCT01216540
- Acronym / sponsor ID
- IIS-000184
- Conditions
- Nephrotoxicity
- Keywords
- vancomycin, nephrotoxicity, length of stay, costs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 7 Oct 2010 (estimated)
- 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.
The primary goal of this study is to determine if there is an association between greater exposure to vancomycin and the development of nephrotoxicity. The secondary goal is to estimate the costs to the hospital associated with these nephrotoxic events.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving vancomycin | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A simple random sample of 400 patients treated with greater than 48 hours of intravenous vancomycin exposure during hospitalization during the time period from July 1, 2009 through June 30, 2010
Key inclusion criteria (5 listed)
- 18 years or older at time of hospital admission
- Had an absolute neutrophil count of ≥ 1000 cells/mm^3
- Received > 48 hours of intravenous vancomycin therapy
- Had one or more vancomycin trough levels reported within the 96 hours after therapy initiation
- Had a baseline serum creatinine level of < 2.0 mg/dL and baseline creatinine clearance level of ≥ 30 mL/min
Key exclusion criteria (1 listed)
- Previous diagnosis of cystic fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to nephrotoxicity
Time frame: within 72 hours post completion of vancomycin therapy
2 secondary outcomes
Hospital costs
Time frame: until discharge
Length of stay
Time frame: until discharge
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 3 Oct 2022.
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Nephrotoxicity
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.
Jack Brown, PharmD principal investigator
State University of New York at Buffalo
Vanessa Stevens, PhD principal investigator
Internal Medicine, Division of Epidemiology, University of Utah School of Medicine
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 Nephrotoxicity, run by University at Buffalo 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 5 inclusion and 1 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 3 Oct 2022. 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 nephrotoxicity (time frame: within 72 hours post completion of vancomycin therapy). 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 3 Oct 2022.