NCT05727293

Brief Summary

A case report of a patient with intellectual disability and neurogenic bladder complicated with sepsis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

September 6, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
Last Updated

May 30, 2023

Status Verified

September 1, 2022

Enrollment Period

1 month

First QC Date

December 4, 2022

Last Update Submit

May 26, 2023

Conditions

Keywords

intellectual disability;Neurogenic bladder;Sepsis ;

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    During the first 3 days of ICU stay

  • Indicators of infection

    Hemameba level

    During the first 6 days of ICU stay

  • C-reaction protein

    Indicators of infection

    During the first 6 days of ICU stay

Interventions

notingOTHER

Non intervention

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A patient with neurogenic cystitis with sepsis and mental retardation.

You may qualify if:

  • Dysgnosia Neurogenic bladder Pyohemia

You may not qualify if:

  • Intellectually normal person No urinary infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

One Case of Individualized Nursing Plan for Sepsis

Guangzhou, Guangdong, 510220, China

Location

Related Publications (4)

  • 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.

  • Wehrberger 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.

  • Dinh 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.

  • von 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.

Study Officials

  • huiying Fuhuiying

    colleague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2022

First Posted

February 14, 2023

Study Start

September 6, 2022

Primary Completion

October 10, 2022

Study Completion

November 6, 2022

Last Updated

May 30, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations