UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030258
Receipt number R000034552
Scientific Title Dexmedetomidine and contrast induced nephropathy in patients undergoing coronary angiography using non-ionic contrast media.
Date of disclosure of the study information 2017/12/04
Last modified on 2017/12/04 17:13:40

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Basic information

Public title

Dexmedetomidine and contrast induced nephropathy in patients undergoing coronary angiography using non-ionic contrast media.

Acronym

Dexmedetomidine and contrast induced nephropathy

Scientific Title

Dexmedetomidine and contrast induced nephropathy in patients undergoing coronary angiography using non-ionic contrast media.

Scientific Title:Acronym

Dexmedetomidine and contrast induced nephropathy

Region

Asia(except Japan)


Condition

Condition

patients undergoing coronary angiography using non-ionic contrast media were recruited into the study

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of Dexmedetomidine administered preoperatively on contrast induced nephropathy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the overall incidence of contrast induced nephropathy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

In group D, a loading dose of 0.001mg/kg dexmedetomidine given over 10 min followed by 0.0005mg/kg/h dexmedetomidine infusion.

Interventions/Control_2

In group S, patients recived the same amount of saline 0.9% infusion.

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

adult patients undergoing coronary angiography were included in this study.

Key exclusion criteria

1,emergency cases;
2,patients with renal failure or diabetes mellitus, patients who were on nephrotoxic and vasoactive drugs simultaneously and patients with decompensated congestive heart failure;
3,patients who had been administered contrast media in the last 2 weeks;

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name chen jie

Organization

Third Military Medical University

Division name

Department of Anaesthesiology, Southwest Hospital,

Zip code


Address

Gaotanyan road, Shapingba, Chongqing, China

TEL

+81-086-23-68754197

Email

cjandsh@tmmu.edu.cn


Public contact

Name of contact person

1st name
Middle name
Last name Chen jie

Organization

Third Military Medical University

Division name

Department of Anaesthesiology, Southwest Hospital,

Zip code


Address

Gaotanyan road, Shapingba, Chongqing, China

TEL

+81-086-23-68754197

Homepage URL


Email

cjandsh@tmmu.edu..cn


Sponsor or person

Institute

Department of Anaesthesiology, Southwest Hospital,

Institute

Department

Personal name



Funding Source

Organization

Department of Anaesthesiology, Southwest Hospital,

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 04 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

2017 Year 11 Month 14 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 16 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

2017 Year 12 Month 04 Day

Last modified on

2017 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034552


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name