UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041236
Receipt No. 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 2020/07/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Nara Medical University
Institute
Department

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 Preinitiation
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 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
2020 Year 07 Month 28 Day
Last modified on
2020 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.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


Contact us.