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MUlticenterS of randomized ControL study Early and adequate protein administration for severe acute pancreatitis

MUlticenterS of randomized ControL study Early and adequate protein administration for severe acute pancreatitis - Muscle study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056504
Enrollment
60
Registered
2024-12-20
Start date
2025-01-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pancreatitis

Interventions

Target doses of protein should be at least 1.2 g/kg on Day 4 and 1.8 g/kg on Days 10-14. 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.

Sponsors

Keio University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine Eisuke Iwasaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
modified pancreatitis activity scoring system (PASS) (Day14)

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactMasayasu Horibe

Keio University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine

masayasu.horibe@gmail.com0353633790

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026