UMIN-CTR Clinical Trial

Basic information
Public title	Oxygen Preconditioning prevents Contrast-Induced Nephropathy after cardiac catheterization
Acronym	OPtionCIN
Scientific Title	Oxygen Preconditioning prevents Contrast-Induced Nephropathy after cardiac catheterization
Scientific Title:Acronym	OPtionCIN
Region	Japan

Condition
Condition	contrast-induced nephropathy
Classification by specialty	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 (oxygen preconditioning)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Incidence of CIN within 48 h of cardiac catheterization
Key secondary outcomes	1) Short-, medium- and long-term prognosis (hemodialysis, total deaths, composite cardiovascular events, whether the patient has been discharged from hospital, duration of hospital stay) within 48 h, 1 month and 6 months after cardiac catheterization 2) Kidney markers within 48 h after cardiac catheterization (creatinine, cystatin C, eGFR, blood and urine beta2 microglobulin, urinary NAG, urinary alpha1 microglobulin, urinary L-FABP, urinary albumin, urinary albumin-to-creatinine ratio, urinary protein, urinary protein-to-creatinine ratio) 3) Kidney markers at 1 and 6 months after cardiac catheterization (creatinine, cystatin C, eGFR, urinary NAG, urinary protein, urinary protein-to-creatinine ratio) 4) Exploratory data analyses regarding risk factors for CIN onset 5) Safety evaluation of oxygen preconditioning by arterial blood gas analysis data (pH, pO2, pCO2, HCO3-, BE, anion gap) 6) Sub-analysis: Sub-analysis conducted with renal dysfunction patients (with GFR<60 mL/min/1.73 m2) 7) Sub-analysis: Sub-analysis conducted in a highly invasive treatment group (further cardiac catheter including PCI and/or PPI during follow-up, surgery under general anesthesia, composite cardiovascular events).

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Oxygen preconditioning group: Single-blinded transnasal oxygen administration (2 L/min) via a high-pressure oxygen cylinder at the time of cardiac catheterization
Interventions/Control_2	Normal air (placebo) group: Single-blinded transnasal normal air administration (2 L/min) via a high-pressure normal air cylinder at the time of cardiac catheterization
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients for whom elective cardiac catheter were scheduled at hospitals belonging to National Hospital Organization
Key exclusion criteria	1) Patients with confirmed or suspected acute coronary syndromes (acute myocardial infarction, unstable angina) 2) Patients presenting shock (systolic blood pressure <90 mmHg) 3) Patients with a history of contrast medium allergy 4) Patients for whom the scheduled procedure is a renal artery intervention 5) Patients in whom the only scheduled contrast study is venography at the time of device surgery or catheter ablation 6) Patients with serum creatinine >= 2.5 mg/dL 7) Patients using a contrast medium within 48 h of scheduled cardiac catheterization 8) Patients with respiratory insufficiency (SpO2 < 90%) 9) Patients with PCO2 > 50 mmHg recorded in arterial blood gas analysis at a time when oxygen was not being administered within 1 month of enrollment 10) Patients with chronic obstructive pulmonary disease or patients with risks for CO2 narcosis (including history of CO2 narcosis) 11) Patients receiving home oxygen therapy 12) Patients in whom oxygen is administered at the time of cardiac catheter or within 12 h of cardiac catheter 13) Patients undergoing hemodialysis or peritoneal dialysis 14) Patients who have taken biguanides within 48 h 15) 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 16) Patients with confirmed or suspected rhabdomyolysis 17) Patients with confirmed or suspected pituitary or adrenal insufficiency 18) Patients with paraquat poisoning 19) Patients who are pregnant or may be pregnant 20) Patients from whom consent for participation in this clinical study was not obtained 21) Patients whose doctors judged them as unsuited to participate in this clinical study 22) Patients during the follow-up period of this clinical study or with the history of participation to this clinical study
Target sample size	1300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoichi Ajiro
Organization	National Hospital Organization Yokohama Medical Center
Division name	Department of Cardiology
Zip code
Address	3-60-2 Harajyuku, Totsuka-ku, Yokohama, Kanagawa
TEL	045-851-2621
Email	optioncin_office@yokohamamc.jp

Public contact
Name of contact person	1st name Middle name Last name Yoichi Ajiro
Organization	National Hospital Organization Yokohama Medical Center
Division name	Department of Cardiology
Zip code
Address	3-60-2 Harajyuku, Totsuka-ku, Yokohama, Kanagawa
TEL	045-851-2621
Homepage URL
Email	optioncin_office@yokohamamc.jp

Sponsor
Institute	National Hospital Organization Yokohama Medical Center
Institute
Department

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

Other related organizations
Co-sponsor
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IRB Contact (For public release)
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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	北海道医療センター(北海道)、帯広病院(北海道)、函館病院(北海道)、水戸医療センター(茨城県)、栃木医療センター(栃木県)、東京医療センター(東京都)、千葉医療センター(千葉県)、埼玉病院(埼玉病院)、横浜医療センター(神奈川県)、相模原病院(神奈川県)、金沢医療センター(石川県)、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)、南和歌山医療センター(和歌山県)、京都医療センター(京都府)、大阪医療センター(大阪府)、神戸医療センター(兵庫県)、米子医療センター(鳥取県)、福山医療センター(広島県)、東広島医療センター(広島県)、岡山医療センター(岡山県)、四国こどもとおとなの医療センター(香川県)、 九州医療センター(福岡県)、長崎川棚医療センター(長崎県)、熊本医療センター(熊本県)、熊本再春荘病院(熊本県)、鹿児島医療センター(鹿児島県)

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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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	Terminated
Date of protocol fixation	2013 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 06 Day
Last follow-up date	2016 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date	2013 Year 12 Month 02 Day
Last modified on	2018 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014325

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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