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Alfapump® system vs...
Alfapump® system vs. large volume paracentesis for refractory ascites : a multicenter randomized controlled study
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Bureau, Christophe (författare)
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Adebayo, Danielle (författare)
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Chalret de Rieu, Mael (författare)
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visa fler...
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Elkrief, Laure (författare)
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Valla, Dominique (författare)
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Peck-Radosavljevic, Markus (författare)
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McCune, Anne (författare)
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Vargas, Victor (författare)
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Simon-Talero, Macarena (författare)
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Cordoba, Juan (författare)
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Angeli, Paolo (författare)
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Rosi, Silvia (författare)
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MacDonald, Stewart (författare)
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Malago, Massimo (författare)
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Stepanova, Maria (författare)
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Younossi, Zobair M. (författare)
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Trepte, Claudia (författare)
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Watson, Randall (författare)
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Borisenko, Oleg (författare)
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- Sun, Sun (författare)
- Umeå universitet,Epidemiologi och global hälsa,Synergus AB, Danderyd, Sweden; Health Outcomes and Economic Evaluation Research Group, Department of Learning, Information, Management and Ethics, Karolinska Institutet, Stockholm, Sweden
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Inhaber, Neil (författare)
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Jalan, Rajiv (författare)
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visa färre...
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(creator_code:org_t)
- Elsevier, 2017
- 2017
- Engelska.
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Ingår i: Journal of Hepatology. - : Elsevier. - 0168-8278 .- 1600-0641. ; 67:5, s. 940-949
- Relaterad länk:
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https://discovery.uc...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- Background and aims: Patients with refractory ascites (RA) require repeated large volume paracenteses (LVP), which involves frequent hospital visits and is associated with a poor quality-of-life. This study assessed safety and efficacy of an automated, low-flow pump (alfapump® [AP]) compared with LVP standard of care [SoC].Methods: A randomized controlled trial, in seven centers, with six month patient observation was conducted. Primary outcome was time to first LVP. Secondary outcomes included paracentesis requirement, safety, health-related quality-of-life (HRQoL), and survival. Nutrition, hemodynamics, and renal injury biomarkers were assessed in a sub-study at three months.Results: Sixty patients were randomized and 58 were analyzed (27 AP, 31 SoC, mean age 61.9years, mean MELD 11.7). Eighteen patients were included in the sub-study. Compared with SoC, median time to first LVP was not reached after six months in the AP group, meaning a significant reduction in LVP requirement for the AP patients (AP, median not reached; SoC, 15.0days (HR 0.13; 95%CI 13.0-22.0; p<0.001), and AP patients also showed significantly improved Chronic Liver Disease Questionnaire (CLDQ) scores compared with SoC patients (p<0.05 between treatment arms). Improvements in nutritional parameters were observed for hand-grip strength (p=0.044) and body mass index (p<0.001) in the sub-study. Compared with SoC, more AP patients reported adverse events (AEs; 96.3% vs. 77.4%, p=0.057) and serious AEs (85.2 vs. 45.2%, p=0.002). AEs consisted predominantly of acute kidney injury in the immediate post-operative period, and re-intervention for pump related issues, and were treatable in most cases. Survival was similar in AP and SoC.Conclusions: The AP system is effective for reducing the need for paracentesis and improving quality of life in cirrhotic patients with RA. Although the frequency of SAEs (and by inference hospitalizations) was significantly higher in the AP group, they were generally limited and did not impact survival.Lay summary: The alfapump® moves abdominal fluid into the bladder from where it is then removed by urination. Compared with standard treatment, the alfapump reduces the need for large volume paracentesis (manual fluid removal by needle) in patients with medically untreatable ascites. This can improve life quality for these patients.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
Nyckelord
- refractory ascites
- liver cirrhosis
- paracentesis
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Bureau, Christop ...
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Adebayo, Daniell ...
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Chalret de Rieu, ...
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Elkrief, Laure
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Valla, Dominique
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Peck-Radosavljev ...
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visa fler...
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McCune, Anne
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Vargas, Victor
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Simon-Talero, Ma ...
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Cordoba, Juan
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Angeli, Paolo
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Rosi, Silvia
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MacDonald, Stewa ...
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Malago, Massimo
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Stepanova, Maria
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Younossi, Zobair ...
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Trepte, Claudia
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Watson, Randall
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Borisenko, Oleg
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Sun, Sun
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Inhaber, Neil
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Jalan, Rajiv
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Hälsovetenskap
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och Folkhälsovetensk ...
- Artiklar i publikationen
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Journal of Hepat ...
- Av lärosätet
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Umeå universitet
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Karolinska Institutet