UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043295
Receipt number R000049436
Scientific Title Effect of early high protein nutrition in critically ill patients: A pilot randomized controlled trial
Date of disclosure of the study information 2021/02/10
Last modified on 2021/02/10 14:59:05

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Basic information

Public title

Effect of early high protein nutrition in critically ill patients

Acronym

Early high protein nutrition in critically ill patients

Scientific Title

Effect of early high protein nutrition in critically ill patients: A pilot randomized controlled trial

Scientific Title:Acronym

Early high protein nutrition in critically ill patients

Region

Japan


Condition

Condition

Diseases seen in ICU

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the effect of early high protein nutrition in patients receiving tube fed mechanical ventilated patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Total amino acid concentration at a week

Key secondary outcomes

length of ICU stay, 28 day mortality, 90 day mortality


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

Intervention group
Amino acid infusion and enteral nutrition are used in combination to achieve a protein dose of 1.5 g / kg / day (1.7 g / kg / day for patients undergoing renal replacement therapy) within 24-48 hours after admission.

Interventions/Control_2

Control group
Intestinal nutrition is started within 24-48 hours after admission, and a protein dose of 1.5 g / kg / day (1.7 g / kg / day for patients undergoing renal replacement therapy) is achieved within a week thereafter.

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

Patients expected to require ventilator management for 3 days or longer

Key exclusion criteria

Patients who cannot use enteral nutrition or do not agree with the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Ginga
Middle name
Last name Suzuki

Organization

Toho University Omori Medical Center

Division name

Critical Care Center

Zip code

143-8541

Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan

TEL

0337624151

Email

ginga.suzuki@med.toho-u.ac.jp


Public contact

Name of contact person

1st name Ginga
Middle name
Last name Suzuki

Organization

Toho University Omori Medical Center

Division name

Critical Care Center

Zip code

143-8541

Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan

TEL

0337624151

Homepage URL


Email

ginga.suzuki@med.toho-u.ac.jp


Sponsor or person

Institute

Toho University Omori Medical Center

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

Toho University Omori Medical Center Ethics Committee

Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan

Tel

03-5763-6534

Email

omori.rinri@ext.toho-u.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

2021 Year 02 Month 10 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2021 Year 01 Month 13 Day

Date of IRB

2017 Year 02 Month 22 Day

Anticipated trial start date

2021 Year 02 Month 10 Day

Last follow-up date

2024 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 02 Month 10 Day

Last modified on

2021 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049436


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name