UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042293
Receipt number R000048283
Scientific Title Investigation of scoring systems for the prediction of the readmission to the intensive care unit in post-operative cardiac surgical patients
Date of disclosure of the study information 2020/10/30
Last modified on 2022/05/01 18:44:31

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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 or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048283


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name