UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041236
Receipt number R000045873
Scientific Title Association between Delirium and GRip Strength in ICU Patients for Cardiac Surgery
Date of disclosure of the study information 2020/08/01
Last modified on 2023/10/26 07:12:02

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Basic information

Public title

Association between Delirium and GRip Strength in ICU Patients for Cardiac Surgery

Acronym

D-GRIP Study

Scientific Title

Association between Delirium and GRip Strength in ICU Patients for Cardiac Surgery

Scientific Title:Acronym

D-GRIP Study

Region

Japan


Condition

Condition

Cardiac surgery

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate whether improving grip strength with short-term grip training before cardiac surgery suppresses postoperative delirium.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of delirium during admission to the intensive care unit

Key secondary outcomes

1) Delirium incidence after POD 2
2) Number of days ICU stays
3) Mortality after 30 days
4) Change rate of WHODAS 2.0


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Intervention group
At the time of the first visit to the outpatient clinic, the left and right grip strength is measured, and a hand gripper with 50% of grip strength is handed over for home training. If the calculated value is not a multiple of 5, since the product is a 5kg-step preparation, we will ask you to select a hand gripper that can be handed in two types, a heavier one and a lighter one. If it is lighter than 5 kg, we will ask you to choose from 5 kg and soft tennis balls.
For training at home, 10-12 grip exercises using a hand gripper should be repeated every 3 sets every day. About 20-30 days of training will be provided until the outpatient day immediately before surgery.

Interventions/Control_2

Control group
No specific therapeutic intervention.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients scheduled for valvular heart surgery
2. Patients scheduled for coronary artery bypass surgery

Key exclusion criteria

1.Patients who are currently being treated in a psychiatry due to a mental illness
2. Patients with a Mini-Mental State Examination score of 21 or less at registration
3. Patients who cannot speak daily conversation in Japanese
4.Patients who have entered the intensive care unit including other hospitals within a past year
5. Compared to the left and right side, patients with strong grip strength >30 kg for men and >20 kg for women
6.Patients with upper limb paralysis who cannot be gripped or trained
7. NYHA IV patients
8.Patients suspected to have symptomatic cerebral ischemia such as syncope due to exercise in the past
9. Patients who have not been extubated within 24 hours after surgery
10. Patients who have offered to withdraw consent after registration
11. Patients who died during surgery or was returned to the ICU after wearing the assisted heart-lung machine
12.Patients who were scheduled for coronary artery bypass surgery without cardiopulmonary bypass, but were treated with cardiopulmonary bypass by intraoperative judgment.

Target sample size

218


Research contact person

Name of lead principal investigator

1st name Yusuke
Middle name
Last name Naito

Organization

Nara Medical University

Division name

Department of Anesthesiology

Zip code

6348522

Address

840 Sijocho Kashihara, Nara

TEL

0744-22-3051

Email

schneider.yusuke@gmail.com


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Naito

Organization

Nara Medical University

Division name

Department of Anesthesiology

Zip code

6348522

Address

840 Sijocho Kashihara, Nara

TEL

0744-22-3051

Homepage URL


Email

schneider.yusuke@gmail.com


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Nara 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

Nara Medical University Bioethics Office

Address

840 Sijocho Kashihara, Nara

Tel

0744-22-3051

Email

ino_rinri@naramed-u.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 08 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

Terminated

Date of protocol fixation

2019 Year 12 Month 21 Day

Date of IRB

2020 Year 06 Month 10 Day

Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2023 Year 08 Month 07 Day

Date of closure to data entry

2023 Year 08 Month 07 Day

Date trial data considered complete

2023 Year 08 Month 07 Day

Date analysis concluded

2023 Year 08 Month 07 Day


Other

Other related information



Management information

Registered date

2020 Year 07 Month 28 Day

Last modified on

2023 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045873


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name