Critical IllnessSEVPBNCT03776409
Safety and Efficacy of Vancomycin Plus Beta-lactams
An observational study of Critical Illness, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The combination of vancomycin and piperacillin-tazobactam has been associated with an increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but it is still unknown if this association exists in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- vancomycin plus piperacillin/tazobactam and vancomycin plus other beta-lactams
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2018to 30 May 2020
- 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: critically ill patients
Who may be able to join
- 18 years or older,
- admitted to intensive care unit
- received the combination of vancomycin and beta-lactams for at least 48 hours
- had a serum creatinine level measured within 24-hour hospital admission
- had at least one VAN level drawn while receiving a combination of study antibiotics
Who cannot join
- pregnancy or lactating patients
- admission to the intensive care unit during administration or within 72 hours of completing the antibiotics
- had end-stage renal disease
- died within 48 hours of combination antibiotic therapy initiation
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Comparison of the Nephrotoxicity of Vancomycin in Combination With Piperacillin/Tazobactam or Other Beta-lactams in Critically Ill Patients: A Retrospective, Multicenter Study in China
The combination of vancomycin and piperacillin-tazobactam has been associated with an increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but it is still unknown if this association exists in critically ill patients. The objective of this study is to compare AKI and efficacy of vancomycin plus piperacillin-tazobactam or beta-lactams.
Read the detailed description
The combination of vancomycin and piperacillin-tazobactam has been associated with an increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but limited data regarding this association exists in critically ill patients. The objective of this study is to compare AKI and efficacy of vancomycin plus piperacillin-tazobactam or beta-lactams.
This is a multicenter, retrospective cohort study. Patients from the retrospective cohort will be divided into 2 groups based on the combination regimen received . Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: basic demographics, diagnosis, concomitant nephrotoxic and other antibiotic medications, serum creatine levels, vancomycin concentrations, and indication for antibiotics.
- Conditions
- Critical Illness
- Being tested
- vancomycin plus piperacillin/tazobactam, vancomycin plus other beta-lactams
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vancomycin plus piperacillin/tazobactamDrug
Patients in intensive care unit who received the combination of VAN(vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours, had a serum creatinine level measured in the 24-hour of hospital admission.The dosage and frequency of VAN and PTZ was adjusted based on clinical practice and patient characteristics.
vancomycin plus other beta-lactamsDrug
Patients in intensive care unit who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics.
| Study group | Role | What they receive |
|---|---|---|
| vancomycin plus piperacillin/tazobactam | Critically ill patients who received the combination of VAN (vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours during an ICU (intensive care unit) admission, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and PTZ were adjusted based on clinical practice and patient characteristics. This is an observational study without any intervention. Receives: Drug: vancomycin plus piperacillin/tazobactam | |
| vancomycin plus other beta-lactams | Critically ill patients who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours during an ICU (intensive care unit) admission, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics. This is an observational study without any intervention. Receives: Drug: vancomycin plus other beta-lactams |
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI(acute kidney injury)
the incidence of acute kidney injury
Measured: from 24 hours after the start of the combination until discharge up to one month
clinical efficacy
microbial eradication
Measured: from 24 hours after the start of the combination until discharge up to one month
Secondary outcomes (6)
the length of hospital stay
Measured: from hospital admission to discharge up to one month
duration of AKI
Measured: the time from AKI onset to resolution of AKI up to one month
onset of AKI
Measured: the first occurence of AKI after starting concomitant antimicrobial use up to one month
whether renal function return to baseline or not
whether defined AKI was resoluted or not
Measured: from AKI onset to resolution of defined AKI up to one month
major acute kidney events at 30 days (MAKE30)
MAKE30 is assessed 30 days following AKI diagnosis, which is a composite outcome of death, new dialysis, and worsened renal function.
Measured: MAKE30 is assessed 30 days following AKI diagnosis
vancomycin trough value assessment
assess the impact of vancomycin exposures on development of AKI
Measured: from hospital admission to discharge up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start12 Dec 2018
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- 700 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University
- Responsible party
- Sponsor
- Investigators
- Yalin Dong, Ph.D, Principal investigator, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776409
- Sponsor's protocol ID
- XJTU1AF2018LSK-169
- Acronym
- SEVPB
- Status last verified
- Dec 2018
- First submitted
- 6 Dec 2018
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Nephrotoxicity of Vancomycin in Combination With Piperacillin/Tazobactam or Other Beta-lactams in Critically Ill Patients: A Retrospective, Multicenter Study in China
- ClinicalTrials.gov ID
- NCT03776409
- Acronym / sponsor ID
- SEVPB / XJTU1AF2018LSK-169
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 14 Dec 2018 (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.
The combination of vancomycin and piperacillin-tazobactam has been associated with an increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but it is still unknown if this association exists in critically ill patients. The objective of this study is to compare AKI and efficacy of vancomycin plus piperacillin-tazobactam or beta-lactams.
Detailed description
The combination of vancomycin and piperacillin-tazobactam has been associated with an increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but limited data regarding this association exists in critically ill patients. The objective of this study is to compare AKI and efficacy of vancomycin plus piperacillin-tazobactam or beta-lactams.
This is a multicenter, retrospective cohort study. Patients from the retrospective cohort will be divided into 2 groups based on the combination regimen received . Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: basic demographics, diagnosis, concomitant nephrotoxic and other antibiotic medications, serum creatine levels, vancomycin concentrations, and indication for antibiotics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vancomycin plus piperacillin/tazobactam | – | Drug: vancomycin plus piperacillin/tazobactamCritically ill patients who received the combination of VAN (vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours during an ICU (intensive care unit) admission, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and PTZ were adjusted based on clinical practice and patient characteristics. This is an observational study without any intervention. |
| vancomycin plus other beta-lactams | – | Drug: vancomycin plus other beta-lactamsCritically ill patients who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours during an ICU (intensive care unit) admission, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics. This is an observational study without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients
Key inclusion criteria (5 listed)
- 18 years or older,
- admitted to intensive care unit
- received the combination of vancomycin and beta-lactams for at least 48 hours
- had a serum creatinine level measured within 24-hour hospital admission
- had at least one VAN level drawn while receiving a combination of study antibiotics
Key exclusion criteria (4 listed)
- pregnancy or lactating patients
- admission to the intensive care unit during administration or within 72 hours of completing the antibiotics
- had end-stage renal disease
- died within 48 hours of combination antibiotic therapy initiation
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 |
|---|---|---|
| vancomycin plus piperacillin/tazobactamPatients in intensive care unit who received the combination of VAN(vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours, had a serum creatinine level measured in the 24-hour of hospital admission.The dosage and frequency of VAN and PTZ was adjusted based on clinical practice and patient characteristics. | Drug | vancomycin plus piperacillin/tazobactam |
| vancomycin plus other beta-lactamsPatients in intensive care unit who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics. | Drug | vancomycin plus other beta-lactams |
Primary outcome
AKI(acute kidney injury)
Time frame: from 24 hours after the start of the combination until discharge up to one month
the incidence of acute kidney injury
clinical efficacy
Time frame: from 24 hours after the start of the combination until discharge up to one month
microbial eradication
6 secondary outcomes
the length of hospital stay
Time frame: from hospital admission to discharge up to one month
duration of AKI
Time frame: the time from AKI onset to resolution of AKI up to one month
onset of AKI
Time frame: the first occurence of AKI after starting concomitant antimicrobial use up to one month
whether renal function return to baseline or not
Time frame: from AKI onset to resolution of defined AKI up to one month
major acute kidney events at 30 days (MAKE30)
Time frame: MAKE30 is assessed 30 days following AKI diagnosis
vancomycin trough value assessment
Time frame: from hospital admission to discharge up to one month
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 23 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Yalin Dong, Ph.D principal investigator
First Affiliated Hospital of Xian Jiaotong University
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 Critical Illness, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 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 23 Jun 2020. 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 China. 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?
AKI(acute kidney injury) (time frame: from 24 hours after the start of the combination until discharge up to one month). The study lists 2 primary outcomes in all. 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 23 Jun 2020.