UMIN-CTR Clinical Trial

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 Obsterics 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
Email	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
Email	kida0430@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054941