UMIN-CTR Clinical Trial

Public title

Oxygen Preconditioning Prevents Contrast-Induced Nephropathy

Acronym

OPtion CIN

Scientific Title

Oxygen Preconditioning Prevents Contrast-Induced Nephropathy

Scientific Title:Acronym

OPtion CIN

Region

Japan

Condition

Ischemic Heart Disease
Congestive Heart Failure
Chronic Kidney Disease
Peripheral arterial Disease

Classification by specialty

Medicine in general	Cardiology	Nephrology
Radiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

OPtion CIN Study is designed to investigate the effect of oxygen preconditioning treatment for preventing the CIN after cardiovascular angiography.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Contrast-Induced Nephropathy : defined as an increase in the serum creatinine concentration of 25 percent or 0.5 mg/dl from the baseline at maximum value obtained within 48 hours after the procedure

Key secondary outcomes

sex, age (more than 70-year-old), hypertension, diabetes mellitus, dyslipidemia, a history of myocardial infarction, BNP(more than 100pg/ml), anemia, use of ACE inhibitors/ARBs, use of diuretics, use of statins, use of contast-medium (more than 150ml), eGFR (less than 60ml/min/1.73m2), PaO2 (more than 100 mmHg)
As sub-analysis, among the patients with eGFR under 60ml/min/1.73m2 for CIN high risk group.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

The control patients were applied intravenous hydration with 0.9 % isotonic saline at a rate of 1ml per kilogram per hour (or 0.5ml per kilogram per hour in the case of low ejection fraction lesser than 40 percent) for 12 hours before and after procedure as the standard prevention.

Interventions/Control_2

In addition to the standard prevention, the oxygen preconditioning patients were administered 2 litters pre minute of nasal pure oxygen from 15 minutes before the canulation until at the end of procedure.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who are scheduled for cardiovascular angiography including diagnostic coronary angiography, ventriculography, aortography, and/or coronary or peripheral intervention.

Key exclusion criteria

peritoneal dialysis, hemodialysis treatment, cardiogenic shock, congestive heart failure, pregnancy, a history of severe allergies to contrast media, recent major bleeding, having a metformin within 48 hours of the study entry, chronic obstructive pulmonary disease, patient with the oxygen saturation lesser than 90 percent, acute coronary syndrome, severe infection, severe malnutrition, post-operative states, pituitary or adrenal dysfunction, paraquat intoxication

Target sample size

400

Name of lead principal investigator

1st name
Middle name
Last name	Haruki Sekiguchi

Organization

Yokohama Medical Center

Division name

Cardiology

Zip code

Address

3-60-2 Harajyuku, Totsuka-ku, Yokohama, Kanagawa

TEL

045-851-2621

Email

Name of contact person

1st name
Middle name
Last name

Organization

Yokohama Medical Center

Division name

Department of Clinical Research

Zip code

Address

3-60-2 Harajyuku, Totsuka-ku, Yokohama, Kanagawa

TEL

045-851-2621

Homepage URL

http://www.yokohama-mc.jp/

Email

Institute

Yokohama Medical Center (Department of Clinical Research)

Institute

Department

Personal name

Organization

Yokohama Medical Center (Department of Clinical Research)

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横浜医療センター病院

Date of disclosure of the study information

2012

Year

01

Month

24

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

http://circ.ahajournals.org/cgi/content/meeting_abstract/124/21_MeetingAbstracts/A13249

Number of participants that the trial has enrolled

Results

The patient in the oxygen preconditioning group had significantly higher PaO2 (134.3 +- 27.7 vs. 90.1 +- 11.7 mmHg, P < 0.01) and significantly lesser incidence of CIN (0.6% vs. 6.1%, odds ratio 0.10, P = 0.01, 95% CI 0.01-0.75) comparing with those in the control group.

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

01

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

04

Month

01

Day

Last follow-up date

2011

Year

08

Month

01

Day

Date of closure to data entry

2011

Year

10

Month

01

Day

Date trial data considered complete

2011

Year

10

Month

01

Day

Date analysis concluded

2011

Year

12

Month

01

Day

Other related information

Registered date

2012

Year

01

Month

24

Day

Last modified on

2012

Year

01

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008386