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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016411
Receipt No. R000019058
Scientific Title Oxygen Preconditioning Prevents Contrast-Induced Nephropathy after contrast-enhanced Computed Tomography
Date of disclosure of the study information 2015/02/01
Last modified on 2015/04/01

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Basic information
Public title Oxygen Preconditioning Prevents Contrast-Induced Nephropathy after contrast-enhanced Computed Tomography
Acronym OPtion CIN-contrast CT
Scientific Title Oxygen Preconditioning Prevents Contrast-Induced Nephropathy after contrast-enhanced Computed Tomography
Scientific Title:Acronym OPtion CIN-contrast CT
Region
Japan

Condition
Condition Contrast-Induced Nephropathy
Classification by specialty
Medicine in general Cardiology Nephrology
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the inhibitory effect on contrast-induced nephropathy (CIN) of oxygenation of arterial blood by oxygen administration prior to the administration of contrast medium in the contrast-enhanced computed tomography
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Incidence of CIN within 72 hours after the contrast enhanced computed tomography
Key secondary outcomes 1) The incidence rate of CIN in control group
2) Exploratory data analysis regarding risk factors of CIN
3) Short- and medium- term prognosis (chronic kidney diseases as the estimated glomerular filtration rate: eGFR less than 60ml/min/1.73m2, hemodialysis, and total death) within 72 hours and 28 days after the contrast enhanced computed tomography
4, 5) Kidney markers at 48 hours and 28 days after the contrast enhanced computed tomography (creatinine, cystatin C, urinary NAG, urinary protein, urinary L-FABP, Nox)
6) Sub-analysis: Sub-analysis conducted with renal dysfunction patients (with eGFR less than 45ml/min/1.73m2)
7) Sub-analysis: Sub-analysis considering of the volume of oral rehydration solution named OS-1)
8) Sub-analysis: Sub-analysis conducted in the level of diabetes mellitus (HbA1c more than or equal 7.0 % or less than 7.0 %)
9) Sub-analysis: Sub-analysis for acute kidney injury (AKI) by categorization of AKIN: Acute Kidney Injury Network
10) Sub-analysis: Sub-analysis for CIN and AKI by eGFR, CLCr: eGFR using Cockcroft-Gault, and eGFR calculated by cystatin C
11) Sub-analysis: Sub-analysis for incidence rate of CIN regarding the type of contrast medium, and the volume of contrast medium

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Oxygen preconditioning group: Single-blinded trans nasal oxygen administration (2L/min) via high-pressure oxygen cylinder 10 to 15 minutes prior to the contrast enhanced computed tomography
Interventions/Control_2 Normal air (placebo) group: Single-blinded trans nasal normal air administration (2L/min) via high-pressure normal air cylinder 10 to 15 minutes prior to the contrast enhanced computed tomography
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

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients for whom the contrast enhanced computed tomography were scheduled at hospitals belonging to National Hospital Organization
Key exclusion criteria 1)Patients within 2 weeks after the acute coronary syndromes (acute myocardial infarction, unstable angina)
2)Patients presenting shock (systolic blood pressure <90 mmHg)
3)Patients with a history of a severe contrast medium allergy
4)Patients with chronic kidney disease which eGFR less than 30 mL/min/1.73m2
5)Patients were administrated the contrast medium within 10 days
6) Patients with oxygen saturation of peripheral artery:SpO2 less than 90% recorded
7)Patients with chronic obstructive pulmonary disease or patients with risks for CO2 narcosis (including history of CO2 narcosis)
8)Patients receiving home oxygen therapy
9)Patients undergoing hemodialysis or peritoneal dialysis
10)Patients who have taken biguanides within 48 hours
11) Patients with severe infections, patients in the perioperative period, or those with serious injury, poor nutritional status, in a starvation state, or state of debility
12)Patients that are scheduled operation within two weeks
13) Patients with confirmed or suspected rhabdomyolysis
14) Patients with confirmed or suspected pituitary or adrenal insufficiency
15) Patients with paraquat poisoning
16)Patients who are pregnant or may be pregnant
17)Patients with piece renal,renal hypoplasia,or nephrectomy (including partial nephrectomy)
18)Patients administrated oxygen 24 hours before the contrast enhanced computed tomography
19)Patients for whom planing the treatment by intravenous drip infusion or oral rehydration therapy
20)Patients will be undergoing emergency computed tomography
21)Patients can not have a oral rehydration therapy
22)Patients whose doctors judged them as unsuited to participate in this clinical study
23)Patients during the follow-up period of this clinical study or with the history of participation to this clinical study
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruki Sekiguchi
Organization National Hospital Organization Yokohama Medical Center
Division name Department of Cardiology, Clinical Research Department
Zip code
Address 3-60-2 Harajyuku, Totsuka-ku, Yokohama, Kanagawa
TEL 045-851-2621
Email sekiguchi.haruki@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimi Seki
Organization National Hospital Organization Yokohama Medical Center
Division name Clinical Research Department
Zip code
Address 3-60-2 Harajyuku, Totsuka-ku, Yokohama, Kanagawa
TEL 045-851-2621
Homepage URL https://www.nhocrc.jp/ebm25page.html
Email o2ct@yokohamamc.jp

Sponsor
Institute National Hospital Organization
Yokohama Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 函館病院(北海道)、高崎総合医療センター(群馬県)、西群馬病院(群馬県)、埼玉病院(埼玉県)、千葉医療センター(千葉県)、千葉東医療センター(千葉県)、横浜医療センター(神奈川県)、まつもと医療センター(長野県)、名古屋医療センター(愛知県)、三重中央医療センター
(三重県)、神戸医療センター(兵庫県)、米子医療センター(鳥取県)、岡山医療センター(岡山県)、福山医療センター(広島県)、九州医療センター(福岡県)、熊本医療センター(熊本県)、沖縄病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 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 Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 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
2015 Year 02 Month 01 Day
Last modified on
2015 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019058

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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