UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058441 |
|---|---|
| Receipt number | R000066822 |
| Scientific Title | Optimal timing for parental nutrition and delivery route of adequate protein in critical care trial |
| Date of disclosure of the study information | 2025/07/12 |
| Last modified on | 2025/07/15 10:37:37 |
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Basic information
Public title
Optimal timing for parental nutrition and delivery route of adequate protein in critical care trial
Acronym
PANDRA trial
Scientific Title
Optimal timing for parental nutrition and delivery route of adequate protein in critical care trial
Scientific Title:Acronym
PANDRA trial
Region
| Japan |
Condition
Condition
Critically ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate 1)optimal delivery route for adequate protein in early enteral nutrition and 2)optial timing for parental nutrition when early enteral nutrition is not possible, in critically ill patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Abilities to perform basic activities of daily living (Barthel Index) at 90 days after randomization
Key secondary outcomes
28-day and 90-day mortality after randomization
Quality of life (EQ-5D-5L) at 90 days after randomization
Hospital-, ICU-, Ventilator-, RRT-free days up to 90 days after randomization
Infectious diseases up to 28 days after randomization
Muscle volume at 7 days and 28 days (or at discharge) after randomization, and changes in muscle volume from randomization to 7 days and 28 days (or at discharge) after randomization
Changes in abilities to perform basic activities of daily living (Barthel Index) from the initiation of intensive care to 90 days after randomization
Severe adverse events up to 90 days after randomization
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(When early enteral nutrition within 48 h after enrollment is possible)
Protein is administered only through the enteral route
Interventions/Control_2
(When early enteral nutrition within 48 h after enrollment is possible)
Protein is administered both through the enteral route and parental (intravenous) route
Interventions/Control_3
(When early enteral nutrition within 48 h after enrollment is not possible)
Parental (intravenous) nutrition is initiated within 60 h after enrollment
Interventions/Control_4
(When early enteral nutrition within 48 h after enrollment is not possible)
Parental (intravenous) nutrition is not initiated until at least 96 h after enrollment
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
18 years old or older
Requiring intensive care
Oral intake nutrition is not possible
Key exclusion criteria
Enteral nutirion has been initiated before enrollment
Withholding or withdrawing of care before enrollment
Consent to participate in the trial cannot be obtained
Ineligible to participate determined by a clinical physician
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Yamamoto |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0332251323
ryoyamamoto@keio.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Yamamoto |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0332251323
Homepage URL
ryoyamamoto@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Ryo Yamamoto
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japanese Society of Intensive Care Medicine
IRB Contact (For public release)
Organization
Keio University School of Medicine, Institutional Review Board
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | 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
| 2025 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066822
