PMID- 34105417
OWN - NLM
STAT- MEDLINE
DCOM- 20220629
LR  - 20220728
IS  - 1718-4304 (Electronic)
IS  - 0896-8608 (Linking)
VI  - 42
IP  - 4
DP  - 2022 Jul
TI  - Preliminary safety study of the Automated Wearable Artificial Kidney (AWAK) in 
      Peritoneal Dialysis patients.
PG  - 394-402
LID - 10.1177/08968608211019232 [doi]
AB  - BACKGROUND: Regeneration of peritoneal dialysis (PD) fluid using sorbent 
      technology can provide flexibility and improve quality of life. This study 
      examined the safety and efficacy of the automated wearable artificial kidney 
      (AWAK) device in PD patients. METHODS: This pilot study included prevalent PD 
      patients from a single center in Singapore between 2016 and 2018. Participants 
      underwent up to nine AWAK therapies over 72 h and were followed up for 1 month. 
      Primary outcomes were serious adverse events (SAEs) and completion of nine 
      therapies without device deficiency. Secondary outcomes were weekly peritoneal 
      Kt/V(urea), solutes clearance and adverse events (AEs). RESULTS: Twenty-one 
      patients were screened and 15 were included in the study. Device alterations were 
      required to overcome issues including flow occlusions initially, which resulted 
      in three cohorts (n = 2, 2 and 11 respectively). No SAEs were observed during the 
      study and at the follow-ups. Common AEs were abdominal pain/discomfort (60%) and 
      bloatedness (47%). The median estimated peritoneal weekly Kt/V(urea) was 3.0 
      (interquartile range: 2.2-4.8). There were significant reductions in pre- and 
      post-study median serum urea (20.8 vs. 14.9 mmol/L; p = 0.001), creatinine (976.0 
      vs. 667.5 micromol/L; p = 0.001), phosphate (1.7 vs. 1.5 mmol/L; p = 0.03), and 
      beta2-microglobulin (29114.0 vs. 26339.0 microg/L; p = 0.048). Fluid reabsorption 
      occurred among patients with residual kidney function. However, median body 
      weights were not significantly different pre- and post-study (66.4 vs. 65.7 kg; p 
      = 0.83). CONCLUSIONS: This preliminary study demonstrated that no SAEs were 
      observed with the AWAK-PD device; however, 60% of participants developed 
      abdominal pain/discomfort. Further device enhancements are needed to improve 
      ultrafiltration and reduce AEs.
FAU - Htay, Htay
AU  - Htay H
AD  - Department of Renal Medicine, Singapore General Hospital, Singapore.
AD  - DUKE-NUS Medical School, Singapore.
FAU - Gow, Sheena K
AU  - Gow SK
AUID- ORCID: 0000-0002-2581-4065
AD  - AWAK Technologies Pte Ltd, Singapore.
FAU - Jayaballa, Mathini
AU  - Jayaballa M
AD  - Department of Renal Medicine, Singapore General Hospital, Singapore.
AD  - DUKE-NUS Medical School, Singapore.
FAU - Oei, Elizabeth L
AU  - Oei EL
AD  - Department of Renal Medicine, Singapore General Hospital, Singapore.
AD  - DUKE-NUS Medical School, Singapore.
FAU - Chan, Choong-Meng
AU  - Chan CM
AD  - Department of Renal Medicine, Singapore General Hospital, Singapore.
AD  - DUKE-NUS Medical School, Singapore.
FAU - Wu, Sin-Yan
AU  - Wu SY
AD  - Department of Renal Medicine, Singapore General Hospital, Singapore.
FAU - Foo, Marjorie Wy
AU  - Foo MW
AD  - Department of Renal Medicine, Singapore General Hospital, Singapore.
AD  - DUKE-NUS Medical School, Singapore.
LA  - eng
PT  - Journal Article
DEP - 20210609
PL  - United States
TA  - Perit Dial Int
JT  - Peritoneal dialysis international : journal of the International Society for 
      Peritoneal Dialysis
JID - 8904033
RN  - 0 (Dialysis Solutions)
RN  - 8W8T17847W (Urea)
RN  - AYI8EX34EU (Creatinine)
SB  - IM
MH  - Abdominal Pain
MH  - Creatinine
MH  - Dialysis Solutions
MH  - Humans
MH  - Kidney
MH  - *Kidney Failure, Chronic/therapy
MH  - *Kidneys, Artificial
MH  - *Peritoneal Dialysis/adverse effects/methods
MH  - Pilot Projects
MH  - Quality of Life
MH  - Urea
MH  - *Wearable Electronic Devices
OTO - NOTNLM
OT  - Artificial kidney
OT  - chronic kidney disease
OT  - peritoneal dialysis
OT  - wearables
EDAT- 2021/06/10 06:00
MHDA- 2022/06/30 06:00
CRDT- 2021/06/09 08:41
PHST- 2021/06/10 06:00 [pubmed]
PHST- 2022/06/30 06:00 [medline]
PHST- 2021/06/09 08:41 [entrez]
AID - 10.1177/08968608211019232 [doi]
PST - ppublish
SO  - Perit Dial Int. 2022 Jul;42(4):394-402. doi: 10.1177/08968608211019232. Epub 2021 
      Jun 9.