UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of scoring systems for the prediction of the readmission to the intensive care unit in post-operative cardiac surgical patients
Acronym	Investigation of scoring systems for the prediction of the readmission to the intensive care unit in post-operative cardiac surgical patients
Scientific Title	Investigation of scoring systems for the prediction of the readmission to the intensive care unit in post-operative cardiac surgical patients
Scientific Title:Acronym	Investigation of scoring systems for the prediction of the readmission to the intensive care unit in post-operative cardiac surgical patients
Region	Japan

Condition
Condition	post-operative cardiac surgery
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Scoring systems such as the National Early Warning Score (NEWS), Sequential Organ Failure Assessment (SOFA) and the Cardiac Surgery Score (CASUS) have been used to assess the status of patients and the severity of organ failure in the intensive care unit. However, the performance for prediction of the readmission to the intensive care unit after cardiac surgery has been unknown. The purpose of this study was to investigate whether NEWS, SOFA, and CASUS can be used to predict ICU/High Care Unit (HCU) readmissions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Readmission to the intensive care unit
Key secondary outcomes	length of post-oprative hospital stay, hospital mortality

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Over 18 years old 2) Patients who have undergone coronary artery bypass grafting, valve replacement or plasty, aortic replacement, or repair of congenital heart disease and admitted to the ICU after surgery.
Key exclusion criteria	Patients who have undergone left ventricular assisted device implantation and heart transplantation
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name SEINO
Organization	Tokyo Women's Medical University
Division name	Department of Intensive Care Medicine
Zip code	162-8666
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	yu-seino@twmu.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name SEINO
Organization	Tokyo Women's Medical University
Division name	Department of Intensive Care Medicine
Zip code	162-8666
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	yu-seino@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Review Board, Tokyo Women's Medical University
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
Tel	03-3353-8111
Email	rinri.bm@twmu.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	2020 Year 10 Month 30 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	Completed
Date of protocol fixation	2020 Year 10 Month 08 Day
Date of IRB	2020 Year 10 Month 13 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other

Other related information

Information on the following items will be obtained and used from the medical records of the study subjects 1. Age, sex, height, and weight 2. Diagnosis, comorbidities, smoking and drinking history 3. Preoperative findings of blood tests, echocardiography and catheterization 4. Operative procedure, extracorporeal circulation time, operative time, anesthesia time, intraoperative fluid volume, intraoperative blood transfusion volume, intraoperative blood loss, intraoperative urine volume 5. Vital signs data in the ICU and HCU, blood gas analysis, drug dosage, fluid volume, blood transfusion volume, ventilator, and time of use of assisted circulation. 6. Length of stay in ICU/HCU and hospital 7. Readmission, cause of readmission, prognosis after readmission, and number of readmission 8. The European System for Cardiac Operative Risk Evaluation (EuroScore II) is calculated based on preoperative laboratory test results and complications. 9. Calculate the NEWS, SOFA and CASUS scores from the ICU or HCU discharge morning from test results and vital signs.

Management information
Registered date	2020 Year 10 Month 30 Day
Last modified on	2022 Year 05 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048283