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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005557
Receipt No. R000006586
Scientific Title Comparisons between 5-Hour Preprocedural hydration vs 20-Hour Preprocedural hydration on Serum Creatinine in Patients with Renal Insufficiency Undergoing an Elective Coronary Procedure
Date of disclosure of the study information 2011/05/06
Last modified on 2011/05/06

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Basic information
Public title Comparisons between 5-Hour Preprocedural hydration vs 20-Hour Preprocedural hydration on Serum Creatinine in Patients with Renal Insufficiency Undergoing an Elective Coronary Procedure
Acronym Comparisons between 5-Hour Preprocedural hydration vs 20-Hour Preprocedural hydration on Serum Creatinine in Patients with Renal Insufficiency Undergoing an Elective Coronary Procedure
Scientific Title Comparisons between 5-Hour Preprocedural hydration vs 20-Hour Preprocedural hydration on Serum Creatinine in Patients with Renal Insufficiency Undergoing an Elective Coronary Procedure
Scientific Title:Acronym Comparisons between 5-Hour Preprocedural hydration vs 20-Hour Preprocedural hydration on Serum Creatinine in Patients with Renal Insufficiency Undergoing an Elective Coronary Procedure
Region
Japan

Condition
Condition chronic kidney disease
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We sought to examine whether 20-hour preprocedural hydration with intravenous isotonic saline (20h-HS) is more effective in the prevention of the contrast-induced increase in serum creatinine than 5-hour preprocedural hydration with intravenous isotonic saline (5h-HS) in patients with renal insufficiency undergoing an elective coronary procedure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint was the absolute and % maximal changes in serum creatinine from the baseline up to 48 hours after contrast exposure.
Key secondary outcomes The secondary endpoints were the incidence of CIN defined as a ≥25% increase in serum creatinine within 48 hours.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 5h-HS (intravenous hydration with isotonic saline for 5 hours before contrast exposure and for 24 hours after contrast exposure)
Interventions/Control_2 20h-HS (intravenous hydration with isotonic saline for 20 hours before contrast exposure and for 24 hours after contrast exposure).
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria were as follows: age of 20 - 85 years; estimated glomerular filtration rate (eGFR) of 15-60 L/min/1.73 m2.
Key exclusion criteria Exclusion criteria were as follows: emergency coronary arteriography or percutaneous coronary intervention, allergy to contrast mediums, pregnancy, intravascular administration of contrast mediums within the preceding 5 days of the study, acute coronary syndrome within the preceding 1 month of the study, severe symptoms of heart failure (New York Heart Association functional class IV), left ventricular ejection fraction <25%, severe hepatic insufficiency, severe chronic respiratory disease, single function kidney, dialysis, and administration of N-acetylcysteine, theophylline, dopamine, or mannitol.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Watanabe
Organization Oita Nakamura Hospital
Division name Division of Cardiovascular Medicine
Zip code
Address 3-2-43 Otemachi, Oita-shi, Oita, Japan 8700022
TEL 097-536-5050
Email

Public contact
Name of contact person
1st name
Middle name
Last name kumie torigoe
Organization Oita Nakamura Hospital
Division name Division of Cardiovascular Medicine
Zip code
Address 3-2-43 Otemachi, Oita-shi, Oita, Japan 8700022
TEL 097-536-5050
Homepage URL
Email kumiet@oita-u.ac.jp

Sponsor
Institute Oita Nakamura Hospital
Institute
Department

Funding Source
Organization This study was performed within medical service under health insurance.
Organization
Division
Category of Funding Organization Other
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 大分中村病院(大分県)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 06 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 Completed
Date of protocol fixation
2010 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 04 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2011 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 05 Month 06 Day
Last modified on
2011 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006586

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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