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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011298
Receipt No. 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

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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
Last 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
Email terashi@m2.kufm.kagoshima-u.ac.jp

Public contact
1st 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
Email terashi@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima Red Cross Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013237

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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