TracheotomyNCT02406079
Impact of Tracheotomy on Procalcitonin
A study testing tracheotomy in people with Tracheotomy, run by First People's Hospital of Chenzhou.
Trial summary
Procalcitonin (PCT) is a reliable biomarker of infection and sepsis. The investigators aimed to determine whether tracheotomy influences PCT concentrations in patients without sepsis, and to assess whether operative duration and procedure affect the peak PCT level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheotomy
- What is being tested?
- tracheotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2014
- Phase
- Interventional
- 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
Who may be able to join
- without sepsis requiring tracheotomy
Who cannot join
- those who did not give their consent or declined treatment during the period of observation
- those with any thyroid diseases past history, such as hyperthyroidism, hypothyroidism and thyroidtumor
- those who received high-dose steroid treatment
- those who received renal replacement therapy (RRT)
- those with severe renal injury (Scr > 300 umol/L)
- those who received antibiotic therapy from 48 hours pre-operation to 72 hours post-operation.
About this study
Official title: Impact of Tracheotomy on Levels of Serum Procalcitonin in Patients Without Sepsis: a Prospective Study
Procalcitonin (PCT) is a reliable biomarker of infection and sepsis. The investigators aimed to determine whether tracheotomy influences PCT concentrations in patients without sepsis, and to assess whether operative duration and procedure affect the peak PCT level.
Read the detailed description
Procalcitonin (PCT), a soluble protein composed of 116 amino acids with a sequence identical to that of the calcitonin prohormone, has been considered as a reliable biomarker for evaluating of bacterial infection and sepsis. In healthy individuals, serum PCT concentrations are undetectable, however, in case of severe bacterial infections and sepsis, it increase rapidly released mainly in peripheral blood mononuclear cells and modulated by bacterial lipopolysaccharides (LPS) and sepsis-associated cytokines. An increase number of studies have demonstrated that PCT-guided strategy is a helpful approach to guide antibiotic administrations and clinical interventions in the intensive care unit (ICU).
However, PCT is induced in the plasmas of patients not only at the presence of bacterial infection, but also in stress conditions such as severe trauma and surgery. In these conditions, the increases are moderate. The mechanism of the nonspecific increase is complicated. Other conditions with elevated PCT concentrations include medullary thyroid carcinoma , cancer, anaphylactic shock, heat shock , cardiac arrest, Kawasaki Disease, and so on. These findings suggest that elevated PCT levels lack the speciality to detect sepsis in critically ill patients.
Tracheotomy is one of most performed surgical procedures to assure airway by making a hole in front of the trachea in ICU. There are studies in literature that show the surgical procedures to the neck area cause a surgical stress, an increase in thyroid hormones. The procedure may due to miscellaneous clinical signs by altering in hormone levels, even creating a thyroid storm. As far as we are aware, there is no study on the impact of tracheotomy on PCT concentration. The aim of the study was to evaluated whether tracheotomy affects PCT concentrations in patients without sepsis. Moreover, the investigators assessed whether operative duration and procedure were correlation with the peak PCT level.
- Conditions
- Tracheotomy
- Being tested
- tracheotomy
- Keywords
- tracheotomy, procalcitonin, sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheotomyProcedure or surgery
Tracheotomy is one of most performed surgical procedures to assure airway by making a hole in front of the trachea in ICU.
| Study group | Role | What they receive |
|---|---|---|
| tracheotomy | Experimental | Not described Receives: Procedure: tracheotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
procalcitonin
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheotomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Chenzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingui Dai, First People's Hospital of Chenzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406079
- Sponsor's protocol ID
- CZ-001
- Status last verified
- Apr 2015
- First submitted
- 25 Mar 2015
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tracheotomy on Levels of Serum Procalcitonin in Patients Without Sepsis: a Prospective Study
- ClinicalTrials.gov ID
- NCT02406079
- Acronym / sponsor ID
- CZ-001
- Conditions
- Tracheotomy
- Keywords
- tracheotomy, procalcitonin, sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- First People's Hospital of ChenzhouUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Apr 2015 (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.
Procalcitonin (PCT) is a reliable biomarker of infection and sepsis. The investigators aimed to determine whether tracheotomy influences PCT concentrations in patients without sepsis, and to assess whether operative duration and procedure affect the peak PCT level.
Detailed description
Procalcitonin (PCT), a soluble protein composed of 116 amino acids with a sequence identical to that of the calcitonin prohormone, has been considered as a reliable biomarker for evaluating of bacterial infection and sepsis. In healthy individuals, serum PCT concentrations are undetectable, however, in case of severe bacterial infections and sepsis, it increase rapidly released mainly in peripheral blood mononuclear cells and modulated by bacterial lipopolysaccharides (LPS) and sepsis-associated cytokines. An increase number of studies have demonstrated that PCT-guided strategy is a helpful approach to guide antibiotic administrations and clinical interventions in the intensive care unit (ICU).
However, PCT is induced in the plasmas of patients not only at the presence of bacterial infection, but also in stress conditions such as severe trauma and surgery. In these conditions, the increases are moderate. The mechanism of the nonspecific increase is complicated. Other conditions with elevated PCT concentrations include medullary thyroid carcinoma , cancer, anaphylactic shock, heat shock , cardiac arrest, Kawasaki Disease, and so on. These findings suggest that elevated PCT levels lack the speciality to detect sepsis in critically ill patients.
Tracheotomy is one of most performed surgical procedures to assure airway by making a hole in front of the trachea in ICU. There are studies in literature that show the surgical procedures to the neck area cause a surgical stress, an increase in thyroid hormones. The procedure may due to miscellaneous clinical signs by altering in hormone levels, even creating a thyroid storm. As far as we are aware, there is no study on the impact of tracheotomy on PCT concentration. The aim of the study was to evaluated whether tracheotomy affects PCT concentrations in patients without sepsis. Moreover, the investigators assessed whether operative duration and procedure were correlation with the peak PCT level.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tracheotomy | Experimental | Procedure: tracheotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- without sepsis requiring tracheotomy
Key exclusion criteria (6 listed)
- those who did not give their consent or declined treatment during the period of observation
- those with any thyroid diseases past history, such as hyperthyroidism, hypothyroidism and thyroidtumor
- those who received high-dose steroid treatment
- those who received renal replacement therapy (RRT)
- those with severe renal injury (Scr > 300 umol/L)
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 |
|---|---|---|
| tracheotomyTracheotomy is one of most performed surgical procedures to assure airway by making a hole in front of the trachea in ICU. | Procedure or surgery | tracheotomy |
Primary outcome
procalcitonin
Time frame: 0-72 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 2 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tracheotomy in people with Tracheotomy, run by First People's Hospital of Chenzhou.
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 1 inclusion and 6 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 2 Apr 2015. 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?
procalcitonin (time frame: 0-72 hours). 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 2 Apr 2015.