UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011298 |
|---|---|
| Receipt number | R000013237 |
| Scientific Title | The influence of dose differences of remifentanil to renal functions in perioperative patients with chronic kidney disease |
| Date of disclosure of the study information | 2013/07/27 |
| Last modified on | 2016/01/27 10:29:35 |
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Basic information
Public title
The influence of dose differences of remifentanil to renal functions in perioperative patients with chronic kidney disease
Acronym
The influence of dose differences of remifentanil to renal functions in perioperative patients with chronic kidney disease
Scientific Title
The influence of dose differences of remifentanil to renal functions in perioperative patients with chronic kidney disease
Scientific Title:Acronym
The influence of dose differences of remifentanil to renal functions in perioperative patients with chronic kidney disease
Region
| Japan |
Condition
Condition
Perioparative adult patients with chronic kidney disease(CKD) undergoing orthopedic surgery
Classification by specialty
| Nephrology | Orthopedics | Anesthesiology |
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the influence of intraoperative variations of administration rate of remifentanil to renal functions in perioperative patients with chronic kidney disease(CKD)
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
estimated glomerular filtratin rate(eGFR)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Remifentanil 1 microgram/kg/min
Interventions/Control_2
Remifentanil 0.5 microgram/kg/min
Interventions/Control_3
Remifentanil 0.25 microgram/kg/min
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
| Not applicable |
Gender
Female
Key inclusion criteria
Perioperative adult patients with CKD (CKD GFR stage 3: 30 =< eGFRcreat < 60) undergoing total hip arthroplasty(THA) or total knee arthroplasty
Key exclusion criteria
Patients with preoparative heart failure, severe valvular disease, not sinus rhythm and obesity(BMI >= 30)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takerou Terashi |
Organization
Kagoshima Red Cross Hospital
Division name
Department of anesthesiology
Zip code
Address
2545 Hirakawa-cho, Kagoshima City, Kagoshima 891-0133, Japan
TEL
099-261-2111
terashi@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takerou Terashi |
Organization
Kagoshima Red Cross Hospital
Division name
Department of anesthesiology
Zip code
Address
2545 Hirakawa-cho, Kagoshima City, Kagoshima 891-0133, Japan
TEL
099-261-2111
Homepage URL
terashi@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagoshima Red Cross Hospital
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
Address
Tel
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
鹿児島赤十字病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 27 | Day |
Last modified on
| 2016 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013237
