HMB study

JRCT ID: jRCT1051210114

Registered date:28/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients scheduled to undergo living donor liver transplantation
• Date of first enrollment: 02/11/2021
• Target sample size: 116
• Study type: Interventional
• Intervention(s): The nutritional supplementation (Abound; Abbott Japan Co., Tokyo, Japan) contained protein mixed Ca-HMB (1500 mg), L-arginine (7000 mg), and L-glutamine (7000 mg) per pack, and patients in the HMB group receive 2 packs per day either orally or enterally for 30 days starting the day after surgery with postoperative rehabilitation. Patients in the control group receive normal postoperative enteral nutrition only with postoperative rehabilitation. The investigators are blinded to the group to which each patient belonged.

Outcome(s)

• Primary Outcome: Skeletal muscle mass index and grip strength at 1 month after living donor liver transplantation (LDLT)

Secondary Outcome

Skeletal muscle mass index and grip strength at 2 months after LDLT
Laboratory data
Incidence of postoperative bacteremia
Length of postoperative hospital stay
Period of enteral nutrition
Period of drainage
Biopsy-proven acute cellular rejection

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 69age old
• Gender: Both

Include criteria

Scheduled to undergo living donor liver transplantation at Kyoto University Hospital
20 years and over at time of registration
Amenable to enteral nutrition
Consents for this study
Does not meet all of the exclusion criteria

Exclude criteria

Re-transplantation
Acute liver failure
History of allergy to HMB-rich nutrients
Cases judged by the investigator to be inappropriate

Related Information

• Primary Sponsor: Hatano Etsuro
• Secondary Sponsor: Kamo Naoko