UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter randomized controlled trial on early fluid resuscitation in extensively burned patients.
Acronym	Burn RCT on fluid resuscitation. (FORECAST Burn)
Scientific Title	A multicenter randomized controlled trial on early fluid resuscitation in extensively burned patients.
Scientific Title:Acronym	Burn RCT on fluid resuscitation. (FORECAST Burn)
Region	Japan

Condition
Condition	Burn
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to verify the effectiveness to attenuate excessive fluid using a resuscitation fluid formula advocated by American Burn Association for Burn Injuries on early resuscitation in extensively burned patients.
Basic objectives2	Others
Basic objectives -Others	The respiratory dysfunction within 1 week after burn (PaO2/FiO2 ratio)
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The respiratory dysfunction within 1 week after burn. (PaO2/FiO2 ratio)
Key secondary outcomes	1. Renal dysfunction within 1 week after burn. (serum creatinine and BUN) 2. Occurrence rate of abdominal compartment syndrome within 28 days after burn. 3. The 28-day and hospital mortality. 4. Fluid volume required within 48 hours after burn.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Dose of Ringer lactate solution (2mL*%TBSA*body weight divided by 2*8 hours is started/4mL*%TBSA*body weight divided by 2*8 hours is started)
Interventions/Control_2	Initial resuscitation period (2 days/2 days)
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	21 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with burn surface area of 20-80%TBSA and age >21 years old.
Key exclusion criteria	Cardiopulmonary arrest Chemical burn Electric burn Case with time interval beyond 4 hours after burn Case received fluid resuscitation before the arrival Comorbidity; heart disease, COPD, chronic renal failure, hepatic cirrhosis. Case combined trauma.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name GANDO
Organization	Hokkaido University Graduate School of Medicine
Division name	Acute and Critical Care Medicine
Zip code	060-8638
Address	N15W7, Kita-ku, Sapporo
TEL	+81-11-706-7377
Email	gando@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Shuta Middle name Last name Fukuda
Organization	Japanese Association for Acute Medicine
Division name	Office
Zip code	113-0033
Address	3-3-12, Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-5840-9870
Homepage URL	https://c.umin.ac.jp/idc/index?proj_id=P00221&ctl=user
Email	editorial-jaam@umin.net

Sponsor
Institute	Japanese Association for Acute Medicine Japanese Society for Burn Injuries
Institute
Department

Funding Source
Organization	Japanese Association for Acute Medicine, Japan Society for the Promotion of the Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido University Graduate School of Medicine
Address	N15W7, Kita-ku, Sapporo
Tel	+81-3-5840-9870
Email	gando@med.hokudai.ac.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	2015 Year 11 Month 16 Day

Related information
URL releasing protocol	http://www.jaam.jp/html/jaamforecast/index.html
Publication of results	Published

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/pii/S2468912221000092?via%3Dihub
Number of participants that the trial has enrolled	39
Results	There were no statistically significant differences between the 2 groups in the serum creatinine, and acute kidney injury based on the KDIGO guideline within 48 h after arrival at the hospital, survival rate on the 28th day, and discharge survival rate. The Modified Brooke formula group failed to achieve the target urine output corresponding to the infusion volume within 8 h after arrival, especially in more than 40% TBSA burn patients, but it did not become a clinical problem.
Results date posted	2021 Year 05 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 03 Month 26 Day
Baseline Characteristics	The inclusion criteria were as follows. More than 21 years old, a burn area of 20%- 80% TBSA, and freely agreed to the contents of the document after giving their informed consent. The exclusion criteria were cardiopulmonary arrest before or on arrival, more than 4 h lapsed from injury to hospitalization, transfer cases with initial resuscitation already started, chemical burn, electric shock burn, history of heart disease (e.g. old myocardial infarction or valvular heart disease), history of chronic respiratory disease (e.g. chronic obstructive pulmonary disease and pulmonary fibrosis), history of renal disorders (e.g. chronic renal failure), liver cirrhosis of Child-Pugh classification C and complicated with trauma with an Abbreviated Injury Scale(AIS) more than 3.
Participant flow	The study design was an exploratory, randomized, open-label, and controlled trial. This randomization was performed by the Pocock method based on the factors of burn surface area, inhalation injury, age, and gender at each facility. The registration of cases and randomization into two groups were performed by participating in registration facilities on the UMIN's website. One group was the conventional group treated using lactated Ringer's solution based on the Baxter formula, and the other was the intervention group treated using the fluid resuscitation method shown in the Modified Brooke formula.
Adverse events	Nothing
Outcome measures	The primary endpoint was a respiratory disorder P/F (PaO2/FiO2) ratio within 1 week after burn injury. The arterial blood sample was collected from an arterial line at the designated time point according to the time of arrival at the hospital, and data were acquired. Therefore, the data obtained by arterial blood sampling at that time show the result of a single data point and not the results of data acquired multiple times. Secondary endpoints were renal disorder (serum creatinine and blood urea nitrogen) within 48 h, the occurrence rate of abdominal compartment syndrome (ACS) within 28 days, survival rate on the 28th day, and volume of fluid resuscitation required for 2 days after hospitalization. We also examined each endpoint, including the urine output per body weight and hour, in the major burn patients with 20%-80% TBSA and with 40%-80% TBSA.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 16 Day
Date of IRB	2015 Year 08 Month 10 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2021 Year 03 Month 26 Day

Other
Other related information

Management information
Registered date	2015 Year 11 Month 10 Day
Last modified on	2021 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022795