UMIN-CTR Clinical Trial

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

Contrast-Induced Nephropathy

Classification by specialty

Medicine in general	Cardiology	Nephrology
Radiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

National Hospital Organization
Yokohama Medical Center

Institute

Department

Personal name

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

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）

Date of disclosure of the study information

2015

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

02

Month

01

Day

Last modified on

2015

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019058