UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005557 |
|---|---|
| Receipt number | 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 11:52:32 |
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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
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
kumiet@oita-u.ac.jp
Sponsor or person
Institute
Oita Nakamura Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006586
