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Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)

2023-08-15Artigo científico Acesso aberto
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dc.contributor.authorPereira, Rui Antunes
dc.contributor.authorVirella, Daniel
dc.contributor.authorPerdigoto, Rui
dc.contributor.authorMarcelino, Paulo
dc.contributor.authorSaliba, Faouzi
dc.contributor.authorGermano, Nuno
dc.contributor.institutionNOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
dc.contributor.pblBioMed Central (BMC)
dc.date.accessioned2023-09-13T22:17:21Z
dc.date.available2023-09-13T22:17:21Z
dc.date.issued2023-08-15
dc.descriptionFunding Information: The authors would like acknowledge and thank the nursing and medical staff at Unidade de Cuidados Intensivos Polivalente 7 (UCIP7), Hospital Curry Cabral, CHULC, for their substantial work and cooperation in this project, as well as Luís Horta, PhD, Ana Luisa Papoila, PhD, and Marta Alves, M.Sc., at the CHULC Research Center for their collaboration and support. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.
dc.description.abstractBackground: Critically ill patients with cirrhosis and ascites are at high risk for intra-abdominal hypertension (IAH) which increases mortality. Clinical guidelines recommend maintaining intra-abdominal pressure (IAP) below 16 mmHg; nonetheless, more than three quarters of critically ill patients with cirrhosis develop IAH during their first week of ICU stay. Standard-of-care intermittent large-volume paracentesis (LVP) relieves abdominal wall tension, reduces IAP, optimizes abdominal perfusion pressure, and is associated with short-term improvement in renal and pulmonary dysfunction. However, there is no evidence of the superiority of different paracentesis strategies in the prevention and treatment of IAH in critically ill patients with cirrhosis. This trial aims to compare the outcomes of continuous passive paracentesis versus LVP in the prevention and treatment of IAH in patients with cirrhosis and ascites. Methods: An investigator-initiated, open label, randomized controlled trial, set in a general ICU specialized in liver disease, was initiated in August 2022, with an expected duration of 36 months. Seventy patients with cirrhosis and ascites will be randomly assigned, in a 1:1 ratio, to receive one of two methods of therapeutic paracentesis. A stratified randomization method, with maximum creatinine and IAP values as strata, will homogenize patient baseline characteristics before trial group allocation, within 24 h of admission. In the control group, LVP will be performed intermittently according to clinical practice, with a maximum duration of 8 h, while, in the intervention group, continuous passive paracentesis will drain ascitic fluid for up to 7 days. The primary endpoint is serum creatinine concentration, and secondary endpoints include IAP, measured creatinine clearance, daily urine output, stage 3 acute kidney injury and multiorgan dysfunction assessed at day 7 after enrollment, as well as 28-day mortality rate and renal replacement therapy-free days, and length-of-stay. Prespecified values will be used in case of renal replacement therapy or, beforehand ICU discharge, liver transplant and death. Safety analysis will include paracentesis-related complication rate and harm. Data will be analyzed with an intention-to-treat approach. Discussion: This is the first trial to compare the impact of different therapeutic paracentesis strategies on organ dysfunction and outcomes in the prevention and treatment of IAH in critically ill patients with cirrhosis and ascites. Trial registration: ClinicalTrials.gov NCT04322201 .en
dc.description.versionpublishersversion
dc.description.versionpublished
dc.format.extent1072905
dc.identifier.doi10.1186/s13063-023-07541-4
dc.identifier.issn1745-6215
dc.identifier.otherPURE: 70240685
dc.identifier.otherPURE UUID: 7e7c318d-e324-4803-827a-eaaa58777d4f
dc.identifier.otherScopus: 85168064019
dc.identifier.otherPubMed: 37582719
dc.identifier.otherWOS: 001049703100001
dc.identifier.urihttp://hdl.handle.net/10362/157748
dc.identifier.urlhttps://www.scopus.com/pages/publications/85168064019
dc.language.isoeng
dc.peerreviewedyes
dc.subjectAbdominal compartment syndrome
dc.subjectAbdominal perfusion pressure
dc.subjectAcute kidney injury
dc.subjectMulti-organ failure
dc.subjectOutcome
dc.subjectRandomized controlled trial
dc.subjectRenal failure
dc.subjectMedicine (miscellaneous)
dc.subjectPharmacology (medical)
dc.titleContinuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)en
dc.title.subtitlestudy protocol for a randomized controlled trialen
dc.typejournal article
degois.publication.issue1
degois.publication.titleTrials
degois.publication.volume24
dspace.entity.typePublication
rcaap.rightsopenAccess

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