臨床研究等提出・公開システム

Randomized controlled trial of b-hydroxy-b-methyl butyrate-enriched formula to improve sarcopenia after liver transplantation

HMB study

Hatano Etsuro

Kyoto University Hospital

54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto-shi

etsuro@kuhp.kyoto-u.ac.jp

Kamo Naoko

Kyoto University Hospital

54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto-shi

+81-75-751-4323

naoko@kuhp.kyoto-u.ac.jp

Recruiting

Oct. 28, 2021

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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

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

Both

Patients scheduled to undergo living donor liver transplantation

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.

Decompensated cirrhosis

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

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

+81-75-753-4680

Oct. 13, 2021

No

none