Septic ShockNCT03308214
The Analysis of Factors Influencing the Vd of Imipenem in Septic Shock Patients
An observational study of Septic Shock, run by Southeast University, China at 1 site in China.
Trial summary
The study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on Vd Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Imipenem
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2018to 28 Dec 2018
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: septic shock patients and non-septic shock patients with the therapy of imipenem in the ICU of Zhongda hospital
Who may be able to join
- age between 18 years old and 80 years old;
- Admitted to the ICU;
- Patients diagnosed as septic shock requiring the therapy of imipenem(0.5g q6h or 1.0g q8h;
Who cannot join
- Patient participated in another interventional trial before enrollment
- Allergy, hypersensitivity or a serious reaction to imipenem;
- Pregnancy.
- patients with ECMO and(or)CRRT.
- tumors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analysis of Factors Influencing the Apparent Volume of Distribution of Imipenem in Septic Shock Patients
The study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on Vd
Read the detailed description
Severe sepsis and septic shock are major causes of mortality in intensive care unit(ICU) patients.Correct and adequate antibiotic coverage is essential but can be complex as a result of fluid resuscitation, hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on pharmacokinetics(PK).Such changes will significantly distort the normal anti-biotic PK profile, resulting in drug exposure that is markedly different from the 'healthy volunteer.'The apparent volume of distribution is one of important PK parameters.Vd determines the loading dose. This review article considers these issues in detail, summarizing the key changes in antibiotic Vd in the critically ill, and providing general suggestions how to optimization of antibiotic dosing to manage Vd challenges.50 patients who receives the theapy of imipenem are included in this study.Whether hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on Vd will be evaluted.
- Conditions
- Septic Shock
- Being tested
- Imipenem
- Keywords
- septic shock; imipenem; VD ;pharmacokinetics
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImipenemDrug
Imipenem 1.0 q 8h
| Study group | Role | What they receive |
|---|---|---|
| septic shock | Patients with septic shock treat with Imipenem Receives: Drug: Imipenem | |
| non-septic shock | Patients with infection but not septic shock treat with Imipenem Receives: Drug: Imipenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
the apparent volume of distribution
The imipenem plasma concentrations are measured at different time to calculate Vd
Measured: Day1, Day 3, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start18 Mar 2018
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songqiao Liu, Southeast University, China
- Investigators
- Songqiao Liu, PHD, Principal investigator, Study Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308214
- Sponsor's protocol ID
- 2017ZDSYLL073-P01
- Status last verified
- Jan 2021
- First submitted
- 25 Sep 2017
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Y, Yang J, Xie J, Liu L, Liu S, Guo F, Qiu H, Yang Y. Association Between Pathophysiology and Volume of Distribution Among Patients With Sepsis or Septic Shock Treated With Imipenem: A Prospective Cohort Study. J Infect Dis. 2020 Mar 16;221(Suppl 2):S272-S278. doi: 10.1093/infdis/jiz651.
PubMed 32176787
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of Factors Influencing the Apparent Volume of Distribution of Imipenem in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT03308214
- Acronym / sponsor ID
- 2017ZDSYLL073-P01
- Conditions
- Septic Shock
- Keywords
- septic shock; imipenem; VD ;pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 18 Mar 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 12 Oct 2017 (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 study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on Vd
Detailed description
Severe sepsis and septic shock are major causes of mortality in intensive care unit(ICU) patients.Correct and adequate antibiotic coverage is essential but can be complex as a result of fluid resuscitation, hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on pharmacokinetics(PK).Such changes will significantly distort the normal anti-biotic PK profile, resulting in drug exposure that is markedly different from the 'healthy volunteer.'The apparent volume of distribution is one of important PK parameters.Vd determines the loading dose. This review article considers these issues in detail, summarizing the key changes in antibiotic Vd in the critically ill, and providing general suggestions how to optimization of antibiotic dosing to manage Vd challenges.50 patients who receives the theapy of imipenem are included in this study.Whether hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on Vd will be evaluted.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| septic shock | – | Drug: ImipenemPatients with septic shock treat with Imipenem |
| non-septic shock | – | Drug: ImipenemPatients with infection but not septic shock treat with Imipenem |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- septic shock patients and non-septic shock patients with the therapy of imipenem in the ICU of Zhongda hospital
Key inclusion criteria (3 listed)
- age between 18 years old and 80 years old;
- Admitted to the ICU;
- Patients diagnosed as septic shock requiring the therapy of imipenem(0.5g q6h or 1.0g q8h;
Key exclusion criteria (5 listed)
- Patient participated in another interventional trial before enrollment
- Allergy, hypersensitivity or a serious reaction to imipenem;
- Pregnancy.
- patients with ECMO and(or)CRRT.
- tumors.
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 |
|---|---|---|
| ImipenemImipenem 1.0 q 8h | Drug | non-septic shock, septic shock |
Primary outcome
the apparent volume of distribution
Time frame: Day1, Day 3, Day 7
The imipenem plasma concentrations are measured at different time to calculate Vd
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 5 Jan 2021.
- Derived from this study: PubMed 32176787Huang Y, Yang J, Xie J, Liu L, Liu S, Guo F, Qiu H, Yang Y. Association Between Pathophysiology and Volume of Distribution Among Patients With Sepsis or Septic Shock Treated With Imipenem: A Prospective Cohort Study. J Infect Dis. 2020 Mar 16;221(Suppl 2):S272-S278. doi: 10.1093/infdis/jiz651.
- Individual participant dataSharing planned: No
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Sepsis
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.
Songqiao Liu, PHD principal investigator
Study Investigator
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 Septic Shock, run by Southeast University, China 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 3 inclusion and 5 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 5 Jan 2021. 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?
the apparent volume of distribution (time frame: Day1, Day 3, Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308214, which also lists 1 linked publication.
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 5 Jan 2021.