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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046075
Receipt No. R000051595
Scientific Title The Effect of Rehabilitation and Dietary Intake on Sleep Disorders in Postoperative Cardiac Surgery Patients: A Single-Center Prospective Observational Study
Date of disclosure of the study information 2021/11/15
Last modified on 2021/11/15

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Basic information
Public title The Effect of Rehabilitation and Dietary Intake on Sleep Disorders in Postoperative Cardiac Surgery Patients: A Single-Center Prospective Observational Study
Acronym sredic trial
(Sleep disorders: the relationship between Rehabilitation and Dietary intake in Cardiac surgery patients)
Scientific Title The Effect of Rehabilitation and Dietary Intake on Sleep Disorders in Postoperative Cardiac Surgery Patients: A Single-Center Prospective Observational Study
Scientific Title:Acronym sredic trial
(Sleep disorders: the relationship between Rehabilitation and Dietary intake in Cardiac surgery patients)
Region
Japan

Condition
Condition postoperative cardiac surgery patients
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate the relationship between rehabilitation and dietary intake on the occurrence of postoperative sleep disturbances in cardiac surgery patients.
Basic objectives2 Others
Basic objectives -Others We hypothesized that rehabilitation and dietary intake would reduce the frequency of sleep disturbances through circadian rhythm adjustments. To test this hypothesis, we designed a single-center prospective observational study of postoperative cardiovascular surgery patients suffering from a high frequency of sleep disorders.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence of sleep disturbance and achievement of rehabilitation and dietary intake in the first postoperative week
Key secondary outcomes Presence of sleep disturbance and achievement of rehabilitation and dietary intake at the time of discharge from the intensive care unit and the second postoperative week

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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Adult patients aged 20 years and older undergoing cardiac surgery from November 16, 2021, to March 31, 2024
Key exclusion criteria Patients who refuse to participate in this observational study including requests from substitutes
Stent graft surgery, including TEVAR, EVAR, AAA
cardiac tamponade, mediastinal lavage
Patients who are unable to answer, fill out, or communicate sleep-related questions including dementia and hearing or speech impairment
Patients who cannot take oral intake
Patients who are unable to undergo rehabilitation intervention
Patients with NYHA, which is the New York Heart Association IV heart failure
Patients undergoing other surgeries within 7 days after surgery
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Bun
Middle name
Last name Aoyama
Organization Kochi Medical School
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code 7838505
Address Kohasu, Oko-cho, Nankoku, Kochi
TEL 0888802471
Email bunaoyama@kochi-u.ac.jp

Public contact
Name of contact person
1st name Bun
Middle name
Last name Aoyama
Organization Kochi Medical School
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code 7838505
Address Kohasu, Oko-cho, Nankoku, Kochi
TEL 0888802471
Homepage URL
Email bunaoyama@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
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 Kochi Medical School
Address Kohasu, Oko-cho, Nankoku, Kochi
Tel 088-880-2180
Email is21@kochi-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 高知大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 15 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
2021 Year 11 Month 15 Day
Date of IRB
2021 Year 10 Month 15 Day
Anticipated trial start date
2021 Year 11 Month 16 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1)The definition of sleep disorder: Richards-Campbell Sleep Questionnaire (RCSQ) score <70. During the sleep assessment, interview about pain (NRS: Numerical Rating Scale), delirium assessment score (CAM-ICU during ICU stay, CAM after ICU discharge), and nausea and vomiting.
2)The ICU nurse records the objective sleep status based on the RCSQ in the ICU.
3)extract the sleeping pills, painkillers, and sedatives used during the night.
4)The progress of rehabilitation: Barthel Index,10m walking speed, grip strength, and FSS-ICU.
5)The achievement of dietary intake: the electronic medical record by classifying calorie and protein intake into oral, intravenous, and enteral.
6)The above information will be investigated before surgery, while in the intensive care unit when leaving the intensive care unit, one week after surgery, and the second week after surgery.
8)Skeletal muscle mass index (Bioelectrical Impedance Analysis; BIA method): preoperatively and at 2 weeks postoperatively. ( body weight, BMI, muscle mass, extracellular water ratio, phase angle, basal metabolic rate, skeletal muscle index) Sarcopenia is diagnosed by combining the medical record findings with the results of the BIA method.
9)Age, gender, height, weight, BMI, cognitive impairment, depression, sleep apnea, ASA-PS classification, NYHA classification, echocardiography findings (LVEF), Hb, Cr, eGFR, CRP, WBC, ALB, Type of cardiac surgery, emergency or scheduled surgery, anesthesia time, cardiopulmonary time, blood loss, blood transfusion volume, total blood transfusion volume, in-out balance, intraoperative urine output, SOFA score, APACHE score, duration of artificial respiration, duration of NPPV and NHF, sedation level during ICU stay RASS (Richmond Agitation-Sedation Scale), Number of days in ICU, presence of alcoholism and smoking, aortic clamp time, use of catecholamines during ICU stay, and use of preoperative sleeping pills, analgesics, and sedatives.


Management information
Registered date
2021 Year 11 Month 15 Day
Last modified on
2021 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051595

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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