Septic ShockNCT03085459
Effects of Nursing Staff on Empiric Antibiotic in Septic Shock
An observational study of Septic Shock and Compliance, run by Chun Pan.
Trial summary
A retrospective, observational study was performed about the patients with septic shock who admitted into intensive care unit (ICU) from January 1, 2015 to February 29, 2016. The number of patients who received empiric antibiotic treatment within first hour after septic shock diagnosis were collected. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock, Compliance, Antibiotic
- What is being tested?
- work Time
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2015to 29 Feb 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients whose age of 18 years or older admitted to the ICU with septic shock from between January 01, 2015 to February 29, 2016
Who may be able to join
- age>18 years old
- sepsis
Who cannot join
- pregnancy
- >80 years old.
About this study
Official title: The Effect of Nursing Staff on Empiric Antibiotic Treatment Within the First Hour in Patients With Septic Shock: A Retrospective Study
A retrospective, observational study was performed about the patients with septic shock who admitted into intensive care unit (ICU) from January 1, 2015 to February 29, 2016. The number of patients who received empiric antibiotic treatment within first hour after septic shock diagnosis were collected. Detailed information about clinical ladder for nursing stuff and nursing shift were collected . Clinical ladder for nursing stuff is a new definition based on education background and work experience and nurses stuff are classified into four levels. N0 was defined who got college degree or above, nurse qualification certificate and working time less than one year. N1 an N2 were defined as who got nurse qualification certificate and working time between 1~3 years and more than three years, respectively. N3 was defined who was nurse-in-charge qualification or got nurse practitioner qualification for more than five years. Compliance of empiric antibiotic treatment within first hour and evaluate the effect of nursing stuff on the compliance were calculated.
- Conditions
- Septic Shock, Compliance, Antibiotic, Nursing Caries
- Being tested
- work Time
- Medical subject headings
- Shock, Septic, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
work TimeBehavioural
nurse got qualification certificate and the working time
| Study group | Role | What they receive |
|---|---|---|
| Nurse level N0 | who got college degree or above, nurse qualification certificate and working time less than one year Receives: Behavioral: work Time | |
| Nurse level N1 | who got nurse qualification certificate and working time between 1~3 years Receives: Behavioral: work Time | |
| Nurse level N2 | who got nurse qualification certificate and working time between 3~5 years Receives: Behavioral: work Time | |
| Nurse level N3 | who got nurse qualification certificate and working time more than 5 years Receives: Behavioral: work Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance of empiric antibiotic treatment within first hour
compliance of empiric antibiotic treatment within first hour
Measured: 1 hour
evaluate the effect of nursing stuff on the compliance
evaluate the effect of nursing stuff on the compliance
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start12 Jan 2015
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chun Pan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chun Pan, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085459
- Sponsor's protocol ID
- Nurse: empiric antibiotic
- Status last verified
- Mar 2017
- First submitted
- 31 Jan 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Staff on Empiric Antibiotic Treatment Within the First Hour in Patients With Septic Shock: A Retrospective Study
- ClinicalTrials.gov ID
- NCT03085459
- Acronym / sponsor ID
- Nurse: empiric antibiotic
- Conditions
- Septic Shock, Compliance, Antibiotic, Nursing Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Chun PanUniversity, hospital or other
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 21 Mar 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.
A retrospective, observational study was performed about the patients with septic shock who admitted into intensive care unit (ICU) from January 1, 2015 to February 29, 2016. The number of patients who received empiric antibiotic treatment within first hour after septic shock diagnosis were collected. Detailed information about clinical ladder for nursing stuff and nursing shift were collected . Clinical ladder for nursing stuff is a new definition based on education background and work experience and nurses stuff are classified into four levels. N0 was defined who got college degree or above, nurse qualification certificate and working time less than one year. N1 an N2 were defined as who got nurse qualification certificate and working time between 1~3 years and more than three years, respectively. N3 was defined who was nurse-in-charge qualification or got nurse practitioner qualification for more than five years. Compliance of empiric antibiotic treatment within first hour and evaluate the effect of nursing stuff on the compliance were calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nurse level N0 | – | Behavioral: work Timewho got college degree or above, nurse qualification certificate and working time less than one year |
| Nurse level N1 | – | Behavioral: work Timewho got nurse qualification certificate and working time between 1~3 years |
| Nurse level N2 | – | Behavioral: work Timewho got nurse qualification certificate and working time between 3~5 years |
| Nurse level N3 | – | Behavioral: work Timewho got nurse qualification certificate and working time more than 5 years |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients whose age of 18 years or older admitted to the ICU with septic shock from between January 01, 2015 to February 29, 2016
Key inclusion criteria (2 listed)
- age>18 years old
- sepsis
Key exclusion criteria (2 listed)
- pregnancy
- >80 years old.
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 |
|---|---|---|
| work Timenurse got qualification certificate and the working time | Behavioural | Nurse level N0, Nurse level N1, Nurse level N2, Nurse level N3 |
Primary outcome
compliance of empiric antibiotic treatment within first hour
Time frame: 1 hour
compliance of empiric antibiotic treatment within first hour
evaluate the effect of nursing stuff on the compliance
Time frame: 1 hour
evaluate the effect of nursing stuff on the compliance
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 21 Mar 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Compliance, run by Chun Pan.
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 2 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
compliance of empiric antibiotic treatment within first hour (time frame: 1 hour). 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 21 Mar 2017.