UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033992 |
|---|---|
| Receipt number | 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 | 2024/09/06 18:20:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Japan |
Condition
Condition
after cardiovascular surgery associated with cardiopulmonary bypass
Classification by specialty
| Cardiovascular surgery |
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
| Medicine |
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
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
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Tadaaki |
| Middle name | |
| Last name | Koyama |
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
| 1st name | Tadaaki |
| Middle name | |
| Last name | Koyama |
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 or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
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
| 2018 | Year | 09 | Month | 03 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/circrep/4/12/4_CR-22-0107/_pdf
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circrep/4/12/4_CR-22-0107/_pdf
Number of participants that the trial has enrolled
240
Results
The primary endpoint was achieved in 78 patients in group C and 77 patients in group T, with no significant difference (P=0.553). In the secondary endpoints, the urinary volume after the start of tolvaptan administration (3 days after surgery) was 2145 ml in group C and 2529 ml in group T (P=0.002), which was significantly higher in group T, and the furosemide dose was 31.8 mg in group C and 23.9 mg in group T (P=0.086), showing a tendency for it to be lower in group T.
Results date posted
| 2024 | Year | 09 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients aged 20 years or older undergoing cardiovascular surgery using cardiopulmonary bypass. Exclusion criteria were chronic renal failure (dialysis or eGFR < 30 ml/min/1.73m2), low cardiac function (EF < 40%), history of hospitalization for heart failure or infection within 4 weeks prior to surgery, semi-urgent or emergency surgery, thoracic/abdominal aortic replacement or coronary artery bypass surgery without cardiopulmonary bypass, and patients who required mechanical ventilation or reintubation for more than 24 hours after surgery.
Participant flow
The control (C) group consisted of 100 patients (azosemide 30 mg/day + furosemide 10-40 mg/day), with 20 excluded cases. The tolvaptan (T) group consisted of 99 patients (azosemide 30 mg/day + furosemide 10-40 mg/day + tolvaptan 3.75 mg/day), with 21 excluded cases.
Adverse events
none
Outcome measures
The primary outcome was whether or not the patient achieved the target weight by the sixth day after surgery. Secondary outcomes were the occurrence of worsening renal function, urinary volume, and postoperative complications.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 02 | Day |
Last modified on
| 2024 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038761
