Sepsis BacterialNCT05727293
A Case Report of a Patient With Intellectual Disability and Neurogenic Bladder Complicated With Sepsis
An observational study of Sepsis Bacterial, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
A case report of a patient with intellectual disability and neurogenic bladder complicated with sepsis Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Sepsis Bacterial
- What is being tested?
- noting
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2022to 6 Nov 2022
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: A patient with neurogenic cystitis with sepsis and mental retardation.
Who may be able to join
- Dysgnosia Neurogenic bladder Pyohemia
Who cannot join
- Intellectually normal person No urinary infection
Trial locations and contacts
1 site in 1 country.
China1 site
One Case of Individualized Nursing Plan for Sepsis
Guangzhou, Guangdong, 510220
About this study
A case report of a patient with intellectual disability and neurogenic bladder complicated with sepsis
Read the detailed description
To summarize the individual care experience of a patient with neurogenic cystitis with sepsis and mental retardation. The main points of nursing care include: conducting personalized nuring care for early sepsis; carring out care for urinary incontinence and urinary tract infection; bulinding health-management plans with family members; and a full course of psychologic diversion that alleviates negative feelings among patients and family members.
- Conditions
- Sepsis Bacterial
- Being tested
- noting
- Keywords
- intellectual disability；Neurogenic bladder；Sepsis ；
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
notingOther
Non intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactic acid
"In some pathological conditions, such as respiratory failure or circulatory failure, tissue hypoxia may be induced, and due to this hypoxia, lactic acid in the body may be elevated." Elevated lactic acid in the body can cause lactic acidosis. Checking the blood lactate level may indicate the severity of the underlying disease.The normal range is 0.05mmol/L-1.7mmol/L.
Measured: During the first 6 days of ICU stay
Sequential Organ Failure Assessment
This scale can describe the dysfunction or failure of individual organs in a continuous form, and can evaluate the degree of mild dysfunction to severe failure. It can be used to measure the occurrence and development of single or whole organ dysfunction repeatedly in clinical research, so as to determine the characteristics describing organ dysfunction or failure, which has a closer relationship with sepsis.
Measured: During the first 3 days of ICU stay
Indicators of infection
Hemameba level
Measured: During the first 6 days of ICU stay
C-reaction protein
Indicators of infection
Measured: During the first 6 days of ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start6 Sep 2022
- Primary completion10 Oct 2022
- Study completion6 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sepsis BacterialStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- huiying Fuhuiying, Principal investigator, colleague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727293
- Sponsor's protocol ID
- SYSKY-2022-469-01
- Status last verified
- Sep 2022
- First submitted
- 4 Dec 2022
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang PY, Meng NH, Chou EC. Voiding dysfunctions in children with mental retardation. Neurourol Urodyn. 2010 Sep;29(7):1272-5. doi: 10.1002/nau.20824.
PubMed 19852064Wehrberger C, Madersbacher S, Jungwirth S, Fischer P, Tragl KH. Lower urinary tract symptoms and urinary incontinence in a geriatric cohort - a population-based analysis. BJU Int. 2012 Nov;110(10):1516-21. doi: 10.1111/j.1464-410X.2012.11022.x. Epub 2012 Mar 12.
PubMed 22409717Dinh A, Hallouin-Bernard MC, Davido B, Lemaignen A, Bouchand F, Duran C, Even A, Denys P, Perrouin-Verbe B, Sotto A, Lavigne JP, Bruyere F, Grall N, Tavernier E, Bernard L. Weekly Sequential Antibioprophylaxis for Recurrent Urinary Tract Infections Among Patients With Neurogenic Bladder: A Randomized Controlled Trial. Clin Infect Dis. 2020 Dec 15;71(12):3128-3135. doi: 10.1093/cid/ciz1207.
PubMed 31867616von Gontard A, Hussong J, Yang SS, Chase J, Franco I, Wright A. Neurodevelopmental disorders and incontinence in children and adolescents: Attention-deficit/hyperactivity disorder, autism spectrum disorder, and intellectual disability-A consensus document of the International Children's Continence Society. Neurourol Urodyn. 2022 Jan;41(1):102-114. doi: 10.1002/nau.24798. Epub 2021 Sep 29.
PubMed 34586694
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Report of a Patient With Intellectual Disability and Neurogenic Bladder Complicated With Sepsis
- ClinicalTrials.gov ID
- NCT05727293
- Acronym / sponsor ID
- SYSKY-2022-469-01
- Conditions
- Sepsis Bacterial
- Keywords
- intellectual disability；Neurogenic bladder；Sepsis ；
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 6 Nov 2022 (actual)
- First posted
- 14 Feb 2023 (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 case report of a patient with intellectual disability and neurogenic bladder complicated with sepsis
Detailed description
To summarize the individual care experience of a patient with neurogenic cystitis with sepsis and mental retardation. The main points of nursing care include: conducting personalized nuring care for early sepsis; carring out care for urinary incontinence and urinary tract infection; bulinding health-management plans with family members; and a full course of psychologic diversion that alleviates negative feelings among patients and family members.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A patient with neurogenic cystitis with sepsis and mental retardation.
Key inclusion criteria (1 listed)
- Dysgnosia Neurogenic bladder Pyohemia
Key exclusion criteria (1 listed)
- Intellectually normal person No urinary infection
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 |
|---|---|---|
| notingNon intervention | Other | – |
Primary outcome
Lactic acid
Time frame: During the first 6 days of ICU stay
"In some pathological conditions, such as respiratory failure or circulatory failure, tissue hypoxia may be induced, and due to this hypoxia, lactic acid in the body may be elevated." Elevated lactic acid in the body can cause lactic acidosis. Checking the blood lactate level may indicate the severity of the underlying disease.The normal range is 0.05mmol/L-1.7mmol/L.
Sequential Organ Failure Assessment
Time frame: During the first 3 days of ICU stay
This scale can describe the dysfunction or failure of individual organs in a continuous form, and can evaluate the degree of mild dysfunction to severe failure. It can be used to measure the occurrence and development of single or whole organ dysfunction repeatedly in clinical research, so as to determine the characteristics describing organ dysfunction or failure, which has a closer relationship with sepsis.
Indicators of infection
Time frame: During the first 6 days of ICU stay
Hemameba level
C-reaction protein
Time frame: During the first 6 days of ICU stay
Indicators of infection
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 30 May 2023.
- Results publication: PubMed 19852064Yang PY, Meng NH, Chou EC. Voiding dysfunctions in children with mental retardation. Neurourol Urodyn. 2010 Sep;29(7):1272-5. doi: 10.1002/nau.20824.
- Results publication: PubMed 22409717Wehrberger C, Madersbacher S, Jungwirth S, Fischer P, Tragl KH. Lower urinary tract symptoms and urinary incontinence in a geriatric cohort - a population-based analysis. BJU Int. 2012 Nov;110(10):1516-21. doi: 10.1111/j.1464-410X.2012.11022.x. Epub 2012 Mar 12.
- Results publication: PubMed 31867616Dinh A, Hallouin-Bernard MC, Davido B, Lemaignen A, Bouchand F, Duran C, Even A, Denys P, Perrouin-Verbe B, Sotto A, Lavigne JP, Bruyere F, Grall N, Tavernier E, Bernard L. Weekly Sequential Antibioprophylaxis for Recurrent Urinary Tract Infections Among Patients With Neurogenic Bladder: A Randomized Controlled Trial. Clin Infect Dis. 2020 Dec 15;71(12):3128-3135. doi: 10.1093/cid/ciz1207.
- Results publication: PubMed 34586694von Gontard A, Hussong J, Yang SS, Chase J, Franco I, Wright A. Neurodevelopmental disorders and incontinence in children and adolescents: Attention-deficit/hyperactivity disorder, autism spectrum disorder, and intellectual disability-A consensus document of the International Children's Continence Society. Neurourol Urodyn. 2022 Jan;41(1):102-114. doi: 10.1002/nau.24798. Epub 2021 Sep 29.
- Individual participant dataSharing planned: No
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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.
huiying Fuhuiying principal investigator
colleague
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 Sepsis Bacterial, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 1 inclusion and 1 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 30 May 2023. 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?
Lactic acid (time frame: During the first 6 days of ICU stay). The study lists 4 primary outcomes in all. 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 NCT05727293, which also lists 4 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 30 May 2023.