UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012468 |
|---|---|
| Receipt number | R000014325 |
| Scientific Title | Oxygen Preconditioning prevents Contrast-Induced Nephropathy after cardiac catheterization |
| Date of disclosure of the study information | 2013/12/03 |
| Last modified on | 2018/05/20 16:08:16 |
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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
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
optioncin_office@yokohamamc.jp
Sponsor or person
Institute
National Hospital Organization
Yokohama Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014325
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