NCT02406079

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
Last Updated

April 2, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

March 25, 2015

Last Update Submit

April 1, 2015

Conditions

Tracheotomy

Keywords

tracheotomyprocalcitoninsepsis

Outcome Measures

Primary Outcomes (1)

  • procalcitonin

    0-72 hours

Study Arms (1)

tracheotomy

EXPERIMENTAL
Procedure: tracheotomy

Interventions

tracheotomyPROCEDURE

Tracheotomy is one of most performed surgical procedures to assure airway by making a hole in front of the trachea in ICU.

tracheotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • without sepsis requiring tracheotomy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Interventions

Tracheotomy

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
First People's Hospital of Chenzhou

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 2, 2015

Study Start

January 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 2, 2015

Record last verified: 2015-04