UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056504 |
|---|---|
| Receipt number | R000064499 |
| Scientific Title | MUlticenterS of randomized ControL study Early and adequate protein administration for severe acute pancreatitis |
| Date of disclosure of the study information | 2024/12/20 |
| Last modified on | 2025/04/16 14:43:38 |
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Basic information
Public title
MUlticenterS of randomized ControL study Early and adequate protein administration for severe acute pancreatitis
Acronym
Muscle study
Scientific Title
MUlticenterS of randomized ControL study Early and adequate protein administration for severe acute pancreatitis
Scientific Title:Acronym
Muscle study
Region
| Japan |
Condition
Condition
Acute pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to test whether early administration of adequate protein is beneficial in patients with severe acute pancreatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
modified pancreatitis activity scoring system (PASS) (Day14)
Key secondary outcomes
modified PASS (Day 4, 7, 10), PASS (Day 4, 7, 10, 14), mortality (at discharge, 1 year), SOFA (Day 14), Barthel Index (Day 28) EQ-5D-5L (Day 28) CRP (Day 14), Alb (Day 14), lymphocyte count (Day 14), phosphorus (Day 14), prealbumin (Day 14), skeletal muscle index at the level of the third lumbar spine by CT (Day 14) mortality due to pancreatitis during hospitalization, severe acute pancreatitis based on the revised Atlanta classification, infected pancreatic necrosis, WON, drainage or necrosectomy for infected pancreatic necrosis, survival discharge days, cost, time from diagnosis to cure of pancreatitis, days in intensive care unit etc, number of days to start oral intake, use and duration of ventilator use, use and duration of dialysis use, use and duration of cardioactive drugs use, new diabetes and insulin use, candida infection, invasive procedure, adverse events (through Day 14)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
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
| Medicine | Food |
Interventions/Control_1
Target doses of protein should be at least 1.2 g/kg on Day 4 and 1.8 g/kg on Days 10-14.
Interventions/Control_2
Target doses of protein are less than 0.6 g/kg on Day 4 and less than 0.9 g/kg on Days 10-14.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosis of pancreatitis: Persistent abdominal pain associated with pancreatitis. Blood lipase (upper limit of normal: 53 IU/L) or amylase (upper limit of normal: 121 IU/L) is elevated more than 3 times the upper limit of normal; CT, MRI, or ultrasound shows abnormal findings associated with pancreatitis. Patients who meet two of the three criteria (including acute exacerbation of chronic pancreatitis)
2. Patients who require admission to a critical care unit (ICU, HCU, emergency, critical care center, etc.) or,have BISAP 3 or higher.
3. SOFA less than 10 points
Key exclusion criteria
1) Patients who are deemed by their physician to be ineligible for nutritional therapy
2) Patients who are deemed unsuitable for this study by their physician (e.g., history of self-discharge)
3) Patients who are not expected to survive longer than one week by the physician
4) Patients who are judged by the physician to be inadequate for adequate protein administration (e.g., concurrent fulminant hepatitis)
5) Patients who do not consent to the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Iwasaki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633790
iwaiwa2007@gmail.com
Public contact
Name of contact person
| 1st name | Masayasu |
| Middle name | |
| Last name | Horibe |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633790
Homepage URL
masayasu.horibe@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Eisuke Iwasaki
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Intensive Care Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
35 Shinanomachi, Shinjuku-ku, Tokyo
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 20 | 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
| 2024 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2024 | Year | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064499
