UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013950 |
|---|---|
| Receipt number | R000016256 |
| Scientific Title | Contribution of Mg supplementation and hight volume hydration to the renal toxicity in patients with lung cancer treated by cisplatin: a historical prospective cohort study. |
| Date of disclosure of the study information | 2014/05/13 |
| Last modified on | 2014/05/13 21:30:20 |
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Basic information
Public title
Contribution of Mg supplementation and hight volume hydration to the renal toxicity in patients with lung cancer treated by cisplatin: a historical prospective cohort study.
Acronym
An examination of reducing the renal toxicity caused by cisplatin.
Scientific Title
Contribution of Mg supplementation and hight volume hydration to the renal toxicity in patients with lung cancer treated by cisplatin: a historical prospective cohort study.
Scientific Title:Acronym
An examination of reducing the renal toxicity caused by cisplatin.
Region
| Japan |
Condition
Condition
lung cancer patients treated with cisplatin
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Objective is the contribution of Mg infusion and high volume hydration to reducing the renal toxicity.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
delta creatinine, delta creatinine clearance
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with malignant chest tumors who were receiving their first cycle of cisplatin-based chemotherapy at the Osaka City University Hospital between December 2011 and October 2013.
Key exclusion criteria
We excluded four patients whose complications or medical histories may have affected their renal function.
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kimura |
Organization
Graduate school of Medicine, Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
81-6-6645-3916
kimutats@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kimura |
Organization
Graduate school of Medicine, Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
81-6-6645-3916
Homepage URL
kimutats@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Graduate school of Medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Graduate school of Medicine, Osaka City University
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 13 | 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
| 2013 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
until December 2012, we performed conventional high-volume hydration without Mg infusion for cases undergoing cisplatin-based chemotherapy (high-volume Mg-). We initiated the administration of Mg sulfate during the pre-hydration stage in December 2012 (high-volume Mg+). Subsequently, the new low-volume hydration with Mg infusion regimen was initiated in July 2013 (low-volume Mg+).
Management information
Registered date
| 2014 | Year | 05 | Month | 13 | Day |
Last modified on
| 2014 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016256
