UMIN-CTR Clinical Trial

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

Burn

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Japanese Association for Acute Medicine
Japanese Society for Burn Injuries

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

11

Month

16

Day

URL releasing protocol

http://www.jaam.jp/html/jaamforecast/index.html

Publication of results

Published

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

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 related information

Registered date

2015

Year

11

Month

10

Day

Last modified on

2021

Year

05

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022795