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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000033992 |
Receipt No. | R000038761 |
Scientific Title | The effect of low dose tolvaptan after cardiovascular surgery |
Date of disclosure of the study information | 2018/09/03 |
Last modified on | 2020/03/06 |
Basic information | ||
Public title | The effect of low dose tolvaptan after cardiovascular surgery | |
Acronym | The effect of low dose tolvaptan after cardiovascular surgery | |
Scientific Title | The effect of low dose tolvaptan after cardiovascular surgery | |
Scientific Title:Acronym | The effect of low dose tolvaptan after cardiovascular surgery | |
Region |
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Condition | ||
Condition | after cardiovascular surgery associated with cardiopulmonary bypass | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | early return to preoperative weight by using tolvaptan after open heart surgery |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Whether returning to the target weight by the 6th postoperative day |
Key secondary outcomes | worsening renal function, urine volume / body weight |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Azosemide 30 mg / day was administered from the 2nd postoperative day. Administer furosemide 10 to 40 mg as appropriate. Within 4 days to return to preoperative weight. | |
Interventions/Control_2 | Azosemide 30 mg/day and tolvaptan 3.75 mg/day was administered from the 2nd postoperative day. Administer furosemide 10 to 40 mg as appropriate. Within 4 days to return to preoperative weight. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | patients after open heart surgery with cardiopulmonary bypass | |||
Key exclusion criteria | Urgency or emergency operation
CKD (dialysis, eGFR<30) Heart failure with EF<40% Heart failure or infection within preoperative 4 weeks Thoracoabdominal aortic replacement surgery and OPCAB Artificial respiration management over 24 hours and reintroduction Tolvaptan allergy Without feeling dry mouth or water ingestion Hypernatremia Patients with pregnant, possibility of pregnancy and pregnancy wish Using tolvaptan preoperatively |
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Target sample size | 240 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kobe City Medical Center General Hospital | ||||||
Division name | Cardiovascular Surgery | ||||||
Zip code | 650-0047 | ||||||
Address | 2-1-1 Minatojimaminamimachi Chuouku Kobe City Hyogo Japan | ||||||
TEL | 078-302-4321 | ||||||
koyamat@kcho.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kobe City Medical Center General Hospital | ||||||
Division name | Cardiovascular Surgery | ||||||
Zip code | 650-0047 | ||||||
Address | 2-1-1 Minatojimaminamimachi Chuouku Kobe City Hyogo Japan | ||||||
TEL | 078-302-4321 | ||||||
Homepage URL | |||||||
koyamat@kcho.jp |
Sponsor | |
Institute | Kobe City Medical Center General Hospital |
Institute | |
Department |
Funding Source | |
Organization | none |
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 | Kobe City Medical Center General Hospital |
Address | 2-1-1 Minatojimaminamimachi Chuouku Kobe City Hyogo Japan |
Tel | 078-302-4321 |
rinken@kcho.jp |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038761 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |