UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053381 |
|---|---|
| Receipt number | R000060916 |
| Scientific Title | Serum albumin levels in patients hospitalized for proximal femur fractures |
| Date of disclosure of the study information | 2024/01/19 |
| Last modified on | 2024/04/19 19:16:37 |
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Basic information
Public title
Serum albumin levels in patients hospitalized for proximal femur fractures
Acronym
N. A.
Scientific Title
Serum albumin levels in patients hospitalized for proximal femur fractures
Scientific Title:Acronym
N. A.
Region
| Japan |
Condition
Condition
Proximal femur fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many patients with proximal femur fractures are undernourished before the injury and complications are exacerbated by the surgical invasion, affecting prognosis, but in addition to preoperative undernutrition, postoperative undernutrition has also been reported to have an impact on life expectancy. Thus, although undernutrition is a risk factor for death and other conditions, these associated factors have not been investigated. In addition, compared to patients at home, institutionalized patients are considered a poor prognostic factor, and institutionalized patients with proximal femur fractures have brought in low nutrition, which may lead to a poor prognosis. In addition, there is a paucity of studies on nutrition in patients admitted with proximal femur fractures in which dieticians intervened. Identification of factors associated with the nutritional status of orthopaedic patients admitted with proximal femur fractures could lead to advances in nutritional guidance and improved prognosis for such patients. The aim of this study was therefore to examine the nutritional status of patients admitted with a proximal femur fracture using a retrospective observational study design.
Basic objectives2
Others
Basic objectives -Others
Risk assessment
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum albumin levels on admission
Key secondary outcomes
Secondary endpoints are admission, during hospitalization and outcome.
Survey items include age, gender, current medical history, medical history (underlying disease), smoking, medication, housing, use of long-term care insurance schemes, height, weight, whole blood (red blood cell count, hemoglobin level, hematocrit level, white blood cell count, total lymphocyte count), serum CRP level, serum total protein level, serum albumin level, serum transthyretin level, serum total cholesterol level, serum triglyceride level, serum HDL cholesterol level, serum LDL cholesterol level, serum urea nitrogen level, serum creatinine level, serum eGFR level, serum Bil level, serum AST level, serum ALT level, serum ALP level, serum GTP level, serum sodium ion concentration, serum potassium ion concentration, serum chloride ion concentration, serum calcium ion concentration, serum phosphorus concentration, GNRI, PNI, CONUT, rehabilitation intervention, nutrition support team intervention, dietary intake, nutritional intake, independence in daily living, activities of daily living, walking ability, intelligence rating scale values, bedsore ulcers, fracture type, days to surgery, operative technique, operative time, intra-operative blood loss, days to start training, post-operative complications, length of stay in hospital and discharge destination.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized with proximal femur fracture at the NHO Kyoto Medical Center.
Key exclusion criteria
Age less than 65 years at the time of enrollment.
Serum albumin level is missing/
Proximal femur fracture caused by high-energy trauma.
Patients who were transferred to another hospital after sustaining a fracture of the femoral neck while hospitalized at another hospital.
Patients who were COVID-19 positive from the time of admission.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Ami |
| Middle name | |
| Last name | Takahashi |
Organization
Doshisha Women's College Graduate School of Liberal Arts
Division name
Human Life and Science
Zip code
602-8580
Address
Teramachi-nishiiru, Imadegawa-dori, Kamigyo-ku, Kyoto 602-0893, Japan
TEL
075-251-4211
is23006@dwc.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Takahashi |
Organization
Doshisha Women's College Graduate School of Liberal Arts
Division name
Human Life and Science
Zip code
602-8580
Address
Teramachi-nishiiru, Imadegawa-dori, Kamigyo-ku, Kyoto 602-0893, Japan
TEL
075-251-4111
Homepage URL
is23006@dwc.doshisha.ac.jp
Sponsor or person
Institute
Doshisha Women's College Graduate School of Liberal Arts
Institute
Department
Personal name
Takahashi Ami
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
NHO Kyoto Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee on Research Involving Human Subjects, Doshisha Women's University
Address
97-1 Okidominamihokotachi, Kyotanabe, Japan
Tel
0774-65-8679
reserch@dwc.doshisha.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
同志社女子大学(Dosisha Women’s College)、国立病院機構京都医療センター (NHO Kyoto Medical Center)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint is Serum albumin levels on admission.
Secondary endpoints are admission, during hospitalization and outcome.
Survey items include age, gender, current medical history, medical history (underlying disease), smoking, medication, housing, use of long-term care insurance schemes, height, weight, whole blood (red blood cell count, hemoglobin level, hematocrit level, white blood cell count, total lymphocyte count), serum CRP level, serum total protein level, serum albumin level, serum transthyretin level, serum total cholesterol level, serum triglyceride level, serum HDL cholesterol level, serum LDL cholesterol level, serum urea nitrogen level, serum creatinine level, serum eGFR level, serum Bil level, serum AST level, serum ALT level, serum ALP level, serum GTP level, serum sodium ion concentration, serum potassium ion concentration, serum chloride ion concentration, serum calcium ion concentration, serum phosphorus concentration, GNRI, PNI, CONUT, rehabilitation intervention, nutrition support team intervention, dietary intake, nutritional intake, independence in daily living, activities of daily living, walking ability, intelligence rating scale values, bedsore ulcers, fracture type, days to surgery, operative technique, operative time, intra-operative blood loss, days to start training, post-operative complications, length of stay in hospital and discharge destination.
Management information
Registered date
| 2024 | Year | 01 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060916
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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