UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035517
Receipt number R000040464
Scientific Title The efficacy of continuous administration of low-dose ketamine during elective on-pump cardiac surgery on hospital length of stay. A Randomised Controlled Trial
Date of disclosure of the study information 2019/01/11
Last modified on 2021/12/31 17:16:34

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Basic information

Public title

The efficacy of continuous administration of low-dose ketamine during elective on-pump cardiac surgery on hospital length of stay.
A Randomised Controlled Trial

Acronym

The efficacy of continuous administration of low-dose ketamine during elective on-pump cardiac surgery on hospital length of stay.
A Randomised Controlled Trial

Scientific Title

The efficacy of continuous administration of low-dose ketamine during elective on-pump cardiac surgery on hospital length of stay.
A Randomised Controlled Trial

Scientific Title:Acronym

The efficacy of continuous administration of low-dose ketamine during elective on-pump cardiac surgery on hospital length of stay.
A Randomised Controlled Trial

Region

Japan


Condition

Condition

Valvular heart disease and ischaemic heart disease

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Continuous administration of low-dose ketamine during elective on-pump cardiac surgery shortens the hospital length of stay after surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

the hospital length of stay after surgery

Key secondary outcomes

Occurrence of delirium
Occurrence of postoperative atrial fibrillation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

control group

Interventions/Control_2

continuous administration of low-dose ketamine group

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

60 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Elective valve surgery (mitral valve/aortic valve) and/or coronary artery bypass surgery with a cardiopulmonary bypass

Key exclusion criteria

Emergency surgery
Redo
Minimally invasive cardiac surgery
carrying ICD
patients who have been diagnosed with cancer
ASA PS 4, 5, 6
Uncontrolled diabetes mellitus
Severe pulmonary diease, asthmatic attack
Current smoker
Hepatic impairment (Child-Pugh A,B,C or aspartate aminotransferase or alanine aminotransferase more than twice the upper normal limit)
Chronic renal insufficiency:serum creatinine level > 2 mg/dL
Immunosuppressive medication (e.g. glucocorticoids)
Cognitive dysfunction, Psychiatric impairment, depression, Parkinson disease, Cerebrovascular disease

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Iwao
Middle name
Last name Usuda

Organization

Saitama Cardiovascular and Respiratory Centre

Division name

Anaesthesiology

Zip code

360-0105

Address

Itai 1696, Kumagaya-city, Saitama 360-0105

TEL

048-536-9900

Email

iusuda-tmhp@umin.ac.jp


Public contact

Name of contact person

1st name General Affairs Department
Middle name
Last name Saitama Cardiovascular and Respiratory Centre

Organization

Saitama Cardiovascular and Respiratory Centre

Division name

General Affairs Department

Zip code

360-0105

Address

Itai 1696, Kumagaya-city, Saitama 360-0105

TEL

048-536-9900

Homepage URL


Email

k369900@pref.saitama.lg.jp


Sponsor or person

Institute

Saitama Cardiovascular and Respiratory Centre

Institute

Department

Personal name



Funding Source

Organization

Saitama prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

General Affairs Department of Saitama Cardiovascular and Respiratory Centre

Address

Itai 1696, Kumagaya-city, Saitama 360-0105

Tel

048-536-9900

Email

k369900@pref.saitama.lg.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

埼玉県立循環器・呼吸器病センター/Saitama Cardiovascular and Respiratory Centre


Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 11 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

2019 Year 01 Month 11 Day

Date of IRB

2018 Year 07 Month 27 Day

Anticipated trial start date

2019 Year 01 Month 11 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 11 Day

Last modified on

2021 Year 12 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040464


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2021/09/03 IwaoUsudaketaUMIN12aug2021jmp.xlsx