Intracranial; Infection, Psychosis, Acute or SubacuteNCT04215094
Early Diagnosis of Intracranial Infection After Craniotomy
An observational study of Intracranial; Infection, Psychosis, Acute or Subacute, run by Pan Jun at 1 site in China.
Trial summary
Intracranial infection are serious complications postoperatively in neurosurgical patients. Early identification of these complications is essential to minimize the mortality and moribidy. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial; Infection, Psychosis, Acute or Subacute
- What is being tested?
- postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2020to 1 Aug 2021
- 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 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postoperative intracranial infection is one of the most serious complications after neurosurgery. At present, there is no prospective study or recognized effective method for its early diagnosis. It is of great significance for a study about early diagnosis of postoperative intracranial infection, In this study, the best diagnostic points of ROC curve will be constructed based on two statistical principles through retrospective study, and then the diagnostic value will be determined through prospective multicenter randomized controlled study. In the research, we will establish quality control system, risk control system and dynamic design to ensure the safety of research subjects and the quality of research results.
Who may be able to join
- craniotomy of brain tumor;
- no clinical manifestations of infection before operation;
- no other infection such as respiratory tract infection, urinary tract infection and deep vein catheter infection before the definite diagnosis of intracranial infection ;
- the patients had informed consent to enter the study.
Who cannot join
- blood system diseases,respiratory tract infection, urinary tract infection and deep vein catheter infection;
- malignant tumors with neuroendocrine characteristicsr;
- aspiration, pancreatitis, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Neurosurgery department, Nanfang hospital
Guangzhou, Guangdong, 510515
xi'an Zhang, MD, PhD, 48831443@qq.com
Junxiang Peng, MD,PHD, pjxlaozong@126.com
About this study
Official title: Role of Postoperative Fever, Serum Procalcitonin, C-reactive Protein and White Blood Cell Count in the Diagnosis of Intracranial Infection After Craniotomy
Intracranial infection are serious complications postoperatively in neurosurgical patients. Early identification of these complications is essential to minimize the mortality and moribidy. The aim of this study is observe the postoperative dynamic changes of body temperature (BT), procalcitonin (PCT), C-reactive protein (CRP), and white blood cell (WBC) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy of intracranial infection.
Read the detailed description
Intracranial infection is a serious complications after neurosurgical operation. Early identification of intracranial infection is important so that, first, optimal treatment is initiated which may improves outcome, second, inappropriate antibiotic treatment and subsequent resistance are prevented, and third, it will promote shorter hospitalization and less cost. In several previous studies, the values of procalcitonin (PCT) and C-reactive protein (CRP) in predicting intracranial infection have been evaluated in neurosurgical patients. However, due to the limited number of studies, the results are not convincing enough and more investigations seems warranted to clarify their dynamic changes in neurosurgical patients without intracranial infection and their role in confirming the suspicion of intracranial infection or excluding intracranial infection from the differential diagnosis.
The aim of the investigator's study is to observe the postoperative dynamic changes of BT, PCT, CRP, and white blood cell (WBC) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy for rational decisions about antibiotic treatment.
- Being tested
- postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun
- Keywords
- Procalcitonin, C-reactive protein, white blood cell count, intracranial infection
- Medical subject headings
- Infections, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative fever, serum procalcitonin, C-reactive protein and white blood cell counDiagnostic test
All patients in Intracranial Infection group were cured with antibiotic treatment
| Study group | Role | What they receive |
|---|---|---|
| infected group | Intracranial infection were diagnosed according to the Centers for Disease Control (CDC) definitions Receives: Diagnostic Test: postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun | |
| non-infected group | the postoperative recovery was uneventful with no infection Receives: Diagnostic Test: postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnosis of intracranial infection after craniotomy
Intracranial infection are serious complications postoperatively in neurosurgical patients. Early identification of these complications is essential to minimize the mortality and moribidy. The aim of this study is observe the postoperative dynamic changes of body temperature (BT), procalcitonin (PCT), C-reactive protein (CRP), and white blood cell (WBC) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy of intracranial infection
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start12 Jan 2020
- Primary completion12 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial; Infection, Psychosis, Acute or SubacuteStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pan Jun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pan Jun, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215094
- Sponsor's protocol ID
- SouthernMUC1
- Status last verified
- Oct 2020
- First submitted
- 28 Nov 2019
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sughrue ME, Bonney PA, Choi L, Teo C. Early Discharge After Surgery for Intra-Axial Brain Tumors. World Neurosurg. 2015 Aug;84(2):505-10. doi: 10.1016/j.wneu.2015.04.019. Epub 2015 Apr 17.
PubMed 25892244Dubey A, Sung WS, Shaya M, Patwardhan R, Willis B, Smith D, Nanda A. Complications of posterior cranial fossa surgery--an institutional experience of 500 patients. Surg Neurol. 2009 Oct;72(4):369-75. doi: 10.1016/j.surneu.2009.04.001. Epub 2009 Jul 14.
PubMed 19604553Chidambaram S, Nair MN, Krishnan SS, Cai L, Gu W, Vasudevan MC. Postoperative Central Nervous System Infection After Neurosurgery in a Modernized, Resource-Limited Tertiary Neurosurgical Center in South Asia. World Neurosurg. 2015 Dec;84(6):1668-73. doi: 10.1016/j.wneu.2015.07.006. Epub 2015 Jul 11.
PubMed 26171888
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Postoperative Fever, Serum Procalcitonin, C-reactive Protein and White Blood Cell Count in the Diagnosis of Intracranial Infection After Craniotomy
- ClinicalTrials.gov ID
- NCT04215094
- Acronym / sponsor ID
- SouthernMUC1
- Keywords
- Procalcitonin, C-reactive protein, white blood cell count, intracranial infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Pan JunUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 12 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 9 Jan 2020 (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.
Intracranial infection are serious complications postoperatively in neurosurgical patients. Early identification of these complications is essential to minimize the mortality and moribidy. The aim of this study is observe the postoperative dynamic changes of body temperature (BT), procalcitonin (PCT), C-reactive protein (CRP), and white blood cell (WBC) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy of intracranial infection.
Detailed description
Intracranial infection is a serious complications after neurosurgical operation. Early identification of intracranial infection is important so that, first, optimal treatment is initiated which may improves outcome, second, inappropriate antibiotic treatment and subsequent resistance are prevented, and third, it will promote shorter hospitalization and less cost. In several previous studies, the values of procalcitonin (PCT) and C-reactive protein (CRP) in predicting intracranial infection have been evaluated in neurosurgical patients. However, due to the limited number of studies, the results are not convincing enough and more investigations seems warranted to clarify their dynamic changes in neurosurgical patients without intracranial infection and their role in confirming the suspicion of intracranial infection or excluding intracranial infection from the differential diagnosis.
The aim of the investigator's study is to observe the postoperative dynamic changes of BT, PCT, CRP, and white blood cell (WBC) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy for rational decisions about antibiotic treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infected group | – | Diagnostic Test: postoperative fever, serum procalcitonin, C-reactive protein and white blood cell counIntracranial infection were diagnosed according to the Centers for Disease Control (CDC) definitions |
| non-infected group | – | Diagnostic Test: postoperative fever, serum procalcitonin, C-reactive protein and white blood cell counthe postoperative recovery was uneventful with no infection |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative intracranial infection is one of the most serious complications after neurosurgery. At present, there is no prospective study or recognized effective method for its early diagnosis. It is of great significance for a study about early diagnosis of postoperative intracranial infection, In this study, the best diagnostic points of ROC curve will be constructed based on two statistical principles through retrospective study, and then the diagnostic value will be determined through prospective multicenter randomized controlled study. In the research, we will establish quality control system, risk control system and dynamic design to ensure the safety of research subjects and the quality of research results.
Key inclusion criteria (4 listed)
- craniotomy of brain tumor;
- no clinical manifestations of infection before operation;
- no other infection such as respiratory tract infection, urinary tract infection and deep vein catheter infection before the definite diagnosis of intracranial infection ;
- the patients had informed consent to enter the study.
Key exclusion criteria (3 listed)
- blood system diseases,respiratory tract infection, urinary tract infection and deep vein catheter infection;
- malignant tumors with neuroendocrine characteristicsr;
- aspiration, pancreatitis, etc.
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 |
|---|---|---|
| postoperative fever, serum procalcitonin, C-reactive protein and white blood cell counAll patients in Intracranial Infection group were cured with antibiotic treatment | Diagnostic test | infected group, non-infected group |
Primary outcome
the diagnosis of intracranial infection after craniotomy
Time frame: up to 100 weeks
Intracranial infection are serious complications postoperatively in neurosurgical patients. Early identification of these complications is essential to minimize the mortality and moribidy. The aim of this study is observe the postoperative dynamic changes of body temperature (BT), procalcitonin (PCT), C-reactive protein (CRP), and white blood cell (WBC) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy of intracranial infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Background: PubMed 25892244Sughrue ME, Bonney PA, Choi L, Teo C. Early Discharge After Surgery for Intra-Axial Brain Tumors. World Neurosurg. 2015 Aug;84(2):505-10. doi: 10.1016/j.wneu.2015.04.019. Epub 2015 Apr 17.
- Results publication: PubMed 19604553Dubey A, Sung WS, Shaya M, Patwardhan R, Willis B, Smith D, Nanda A. Complications of posterior cranial fossa surgery--an institutional experience of 500 patients. Surg Neurol. 2009 Oct;72(4):369-75. doi: 10.1016/j.surneu.2009.04.001. Epub 2009 Jul 14.
- Results publication: PubMed 26171888Chidambaram S, Nair MN, Krishnan SS, Cai L, Gu W, Vasudevan MC. Postoperative Central Nervous System Infection After Neurosurgery in a Modernized, Resource-Limited Tertiary Neurosurgical Center in South Asia. World Neurosurg. 2015 Dec;84(6):1668-73. doi: 10.1016/j.wneu.2015.07.006. Epub 2015 Jul 11.
- Individual participant dataSharing planned: No
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.
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 Intracranial; Infection, Psychosis, Acute or Subacute, run by Pan Jun 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xi'an Zhang, doctor (+86-020-61641815, 48831443@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnosis of intracranial infection after craniotomy (time frame: up to 100 weeks). 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 NCT04215094, which also lists 3 linked publications.
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 Oct 2020.