UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048214 |
|---|---|
| Receipt number | R000054941 |
| Scientific Title | Prognostic factors using red cell distribution width (RDW) in perioperative patients |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/06/30 18:02:34 |
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Basic information
Public title
Prognostic factors using red cell distribution width (RDW) in perioperative patients
Acronym
RDW in perioperative patients
Scientific Title
Prognostic factors using red cell distribution width (RDW) in perioperative patients
Scientific Title:Acronym
RDW in perioperative patients
Region
| Japan |
Condition
Condition
Surgical patient undergoing general anesthesia
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Pediatrics |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Anesthesiology | Oral surgery | Neurosurgery |
| Cardiovascular surgery | Plastic surgery | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The risk of perioperative complications tends to increase with the aging of society and the development of surgical techniques and anesthesia methods. However, available medical resources are limited, and it is difficult to allocate the same amount of medical resources to all patients. If perioperative patient risk can be easily assessed, patient outcomes can be improved by focusing medical resources on high risk patients. Currently, risk assessment for each disease and organ is widely performed, but perioperative prognosis is generally judged comprehensively by attending physicians and anesthesiologists based on individual risk assessments, which is not easy to perform and is not accurate. Red cell distribution width (RDW) is an inexpensive measure of red cell size variability that has been associated with hematologic disorders, iron deficiency anemia, and bone marrow dysfunction. Values above the normal range reflect the presence of small and large erythrocytes. Recently, RDW has been reported to be a useful prognostic marker for patients with chronic diseases and is considered a strong independent risk factor for mortality. More recently, RDW has also been reported to be useful as a short and long term prognostic marker for acute illnesses such as sepsis. In the perioperative period, RDW has been studied in adult noncardiac surgical patients, but its usefulness in predicting life expectancy and perioperative complications in a variety of conditions, including cardiac surgery patients, surgical patients with coexisting sepsis, emergency patients, and pediatric surgical patients is not known. To develop a simple short and long term prognostic marker for surgical patients. This study will establish a simple method to predict prognosis in surgical patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
30 days and 1 year postoperative death
Key secondary outcomes
Complications during the perioperative period, during intensive care unit stay, during admission
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent surgery under general anesthesia in our operating room under intubation from January 1, 2014 to April 01, 2023.
Key exclusion criteria
RDW unmeasured
Target sample size
13000
Research contact person
Name of lead principal investigator
| 1st name | HIROMASA |
| Middle name | |
| Last name | KIDA |
Organization
Kanazawa Medical University
Division name
Anesthesiology
Zip code
9200293
Address
1-1, Uchida University, Kawakita-gun, Ishikawa
TEL
0762862211
kida0430@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | HIROMASA |
| Middle name | |
| Last name | KIDA |
Organization
Kanazawa Medical University
Division name
Anesthesiology
Zip code
9200293
Address
1-1, Uchida University, Kawakita-gun, Ishikawa
TEL
0762862211
Homepage URL
kida0430@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa Medical University
Address
1-1, Uchida University, Kawakita-gun, Ishikawa
Tel
0762862211
kida0430@kanazawa-med.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood pressure, heart rate, SpO2, arterial blood gas, central venous pressure, pulmonary artery pressure, and the presence of complications (heart failure, pulmonary edema, abnormal hypertension, etc.) from the induction of anesthesia to 72 hours after surgery Hematological examination (hemoglobin, white blood cell count, platelet count, RDW) Biochemical examination (ALP, total bilirubin, albumin, AST, ALT, total protein, LDH, creatinine, BUN, Na, K, Cl) Postoperative 30-day and 1year death, perioperative complications, intensive care unit stay Duration of stay in intensive care unit, duration of hospitalization
Management information
Registered date
| 2022 | Year | 06 | Month | 30 | Day |
Last modified on
| 2022 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054941
