UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046075 |
|---|---|
| Receipt number | 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 | 2024/04/17 08:55:43 |
* 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
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
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
bunaoyama@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
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
Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku, Kochi
Tel
088-880-2180
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
Completed
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
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051595
