UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037074 |
|---|---|
| Receipt number | R000042215 |
| Scientific Title | Blood pressure and Relative Optimal Target after Heart surgery in Epidemiologic Registry |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2021/12/21 20:12:20 |
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Basic information
Public title
Blood pressure and Relative Optimal Target after Heart surgery in Epidemiologic Registry
Acronym
BROTHER study
Scientific Title
Blood pressure and Relative Optimal Target after Heart surgery in Epidemiologic Registry
Scientific Title:Acronym
BROTHER study
Region
| Japan |
Condition
Condition
coronary artery bypass grafting and/or valve surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current blood pressure management in patients admitted to intensive care unit (ICU) after cardiac surgery and the association between blood pressure management and patient outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute kidney injury
Key secondary outcomes
Mortality
Renal replacement therapy
MAKE (Major Adverse Kidney Events)
Fluid balance
Amount of hemorrhage
Atrial fibrillation
Stroke
Non-occlusive mesenteric ischemia
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults (>=18 years of age) admitted to ICU after coronary artery bypass grafting and/or valve surgery between January 1st 2018 and December 31st 2018
Key exclusion criteria
Patients discharged from ICU within 24 hours from ICU admission
Emergency surgery
Patients with extracorporeal membrane oxygenation (ECMO), intra-aortic ballon pumping (IABP), or ventricular assist device (VAD) within the first 24 hours from ICU admission
Patients without the documentation of blood pressure between the day before surgery and 365 days before surgery
Patients with invasive arterial blood pressure recordings at more than 1 hour interval
Target sample size
407
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kotani |
Organization
Kameda Medical Center
Division name
Department of Intensive Care Medicine
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa, Japan
TEL
04-7092-2211
dkivoar287@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kotani |
Organization
Kameda Medical Center
Division name
Department of Intensive Care Medicine
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa, Japan
TEL
04-7092-2211
Homepage URL
dkivoar287@gmail.com
Sponsor or person
Institute
Kameda Medical Center, Department of Intensive ACare Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda Medical Center, Clinical Research Committee
Address
929 Higashi-cho, Kamogawa, Japan
Tel
04-7092-2211
clinical_research@kameda.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
| 2019 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://annalsofintensivecare.springeropen.com/articles/10.1186/s13613-021-00969-4
Publication of results
Published
Result
URL related to results and publications
https://annalsofintensivecare.springeropen.com/articles/10.1186/s13613-021-00969-4
Number of participants that the trial has enrolled
746
Results
One-hundred-and-twenty patients (16.1%) experienced AKI progression. In the multivariable analyses, time-weighted-average MPP-deficit was not associated with AKI progression. Likewise, time spent with MPP-deficit？>？20% was not associated with AKI progression. Among exploratory exposure variables, time-weighted-average CVP, time-weighted-average MPP, and time spent with MPP？<？60 mmHg were associated with AKI progression.
Results date posted
| 2021 | Year | 12 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
One-hundred-and-twenty patients (16%) had AKI progression. The median age was 71 years, and most patients (73%) had chronic hypertension. Among the vasopressors and inotropes used in the first 24 h, dobutamine was the most frequently used drug (53%), followed by norepinephrine (40%). The baseline serum creatinine level was higher in the AKI group. Although preoperative MAP was similar between the two groups, preoperative MPP was lower in the AKI group.
Participant flow
Among 1568 adult patients admitted to the ICUs after CABG or valve surgery between January and December 2018, we registered 870 patients on the BROTHER study. During the data collection period of this study, a pandemic of COVID-19 occurred, which made data collection difficult for some investigators, and we could not enroll 42 patients. After excluding 124 patients, we analyzed 746 patients. No patients were lost to follow-up.
Adverse events
Not applicable.
Outcome measures
One-hundred-and-twenty patients (16%) had AKI progression. Seven patients (0.9%) experienced MAKE30, and hospital mortality occurred in four patients (0.5%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: multicenter retrospective cohort study
Inclusion criteria: adults (>=18 years of age) who underwent elective coronary artery bypass grafting and/or valve surgery and were admitted to a ICU in Japan between January 2017 and December 2018.
Exclusion criteria: 1) patients with ECMO, IABP, or VAD, 2) readmissions, 3) patients who stayed ICU for <24 hours
Variables: hemodynamic parameters during the first 24 hours from ICU admission, serum creatinine level and urine output during first 72 hours from ICU admission, baseline characteristics, operation information, and outcomes at ICU and hospital discharge
Management information
Registered date
| 2019 | Year | 06 | Month | 14 | Day |
Last modified on
| 2021 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042215
