UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dexmedetomidine and contrast induced nephropathy in patients undergoing coronary angiography using non-ionic contrast media.
Title of the study (Brief title)	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	chen jie
Organization	Third Military Medical University
Division name	Department of Anaesthesiology, Southwest Hospital,
Address	Gaotanyan road, Shapingba, Chongqing, China
TEL	+81-086-23-68754197
Email	cjandsh@tmmu.edu.cn

Public contact
Name of contact person	Chen jie
Organization	Third Military Medical University
Division name	Department of Anaesthesiology, Southwest Hospital,
Address	Gaotanyan road, Shapingba, Chongqing, China
TEL	+81-086-23-68754197
Homepage URL
Email	cjandsh@tmmu.edu..cn

Sponsor
Institute	Department of Anaesthesiology, Southwest Hospital,
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034552