UMIN-CTR Clinical Trial

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
Email	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
Email	dkivoar287@gmail.com

Sponsor
Institute	Kameda Medical Center, Department of Intensive ACare Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042215