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Trials Aug 2023Critically ill patients with cirrhosis and ascites are at high risk for intra-abdominal hypertension (IAH) which increases mortality. Clinical guidelines recommend...
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): study protocol for a randomized controlled trial.
BACKGROUND
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 . Registered on 20 December 2019.
Topics: Humans; Paracentesis; Ascites; Critical Illness; Intra-Abdominal Hypertension; Creatinine; Liver Cirrhosis; Randomized Controlled Trials as Topic
PubMed: 37582719
DOI: 10.1186/s13063-023-07541-4 -
Diagnostic and Interventional Radiology... Mar 2022PURPOSE Paracentesis is commonly performed in interventional radiology practice, and large volume paracentesis (LVP) using wall suction can take up to an hour to...
PURPOSE Paracentesis is commonly performed in interventional radiology practice, and large volume paracentesis (LVP) using wall suction can take up to an hour to complete, placing significant stress on room and resource time. As the number of LVP procedures performed by Interventional Radiologists continue to increase, this study was undertaken to analyze the impact of the RenovaRP® Paracentesis Management System (GI Supply) on procedure time and patient satisfaction. METHODS Between March 9, 2020 and May 29, 2020, procedural data and patient satisfaction was collected as part of a practice quality improvement project and retrospectively analyzed on 39 sequential paracenteses performed with wall suction prior to acquiring the RenovaRP® system and subsequently on 42 paracenteses performed with use of the device. RESULTS A substantially higher fluid flow rate was found using the RenovaRP® system compared to wall suction, 237.2 mL/min vs. 108.6 mL/min (P < .001). This resulted in a significant decrease in procedure room time from 53 min to 31 min (P < .001). There was associated improvement in the patient experience during paracentesis. CONCLUSION The RenovaRP® decreases procedure time for LVP with improvement in the patient experience during paracentesis.
Topics: Ascites; Humans; Liver Cirrhosis; Paracentesis; Retrospective Studies; Suction
PubMed: 35548901
DOI: 10.5152/dir.2022.20991 -
Ultraschall in Der Medizin (Stuttgart,... Oct 2015
Topics: Biopsy, Needle; Humans; Paracentesis; Sensitivity and Specificity; Ultrasonography, Interventional
PubMed: 26468770
DOI: 10.1055/s-0035-1553664 -
JACC. Cardiovascular Imaging Apr 2018
Topics: Echocardiography; Humans; Incidence; Pericardial Effusion; Pericardiocentesis; Pericarditis, Constrictive
PubMed: 29622178
DOI: 10.1016/j.jcmg.2017.10.028 -
The National Medical Journal of India 1992
Topics: Amniocentesis; Clinical Protocols; Female; Humans; Pregnancy; Pregnancy Trimester, Second; Pregnancy Trimester, Third; Specimen Handling
PubMed: 1304245
DOI: No ID Found -
British Medical Journal Jul 1964
Topics: Amniocentesis; Female; Humans; Pregnancy
PubMed: 14150882
DOI: 10.1136/bmj.2.5402.136 -
Digestive Diseases (Basel, Switzerland) 2005Patients with cirrhosis have significant abnormalities in their fluid and electrolyte balance; this is manifested mainly by the development of ascites and edema. Ascites... (Review)
Review
Patients with cirrhosis have significant abnormalities in their fluid and electrolyte balance; this is manifested mainly by the development of ascites and edema. Ascites is the most common complication of patients with cirrhosis and its development constitutes the first and most important manifestation of the disease. With disease progression, patients with advanced cirrhosis and severe urinary sodium retention develop refractory ascites, a condition in which patients do not respond to diuretics or develop severe side effects to these that preclude their use. This condition occurs in 5-10% of cases admitted to the hospital for treatment of ascites. Approximately half of these patients will die within 1 year if not transplanted; therefore, the best therapy is liver transplantation in suitable candidates. During the last two decades, significant advances have been made in regard to pathogenesis and treatment of refractory ascites. The re-introduction of therapeutic paracentesis with plasma expansion in the 1980s was a milestone in the treatment of these patients. In addition, the introduction of transjugular intrahepatic portosystemic shunts as a therapy for refractory ascites has certainly provided a reasonable alternative for those patients with preserved liver function and unwilling to undergo several taps per month. This article will discuss the pathophysiology, clinical features and therapy of refractory ascites in cirrhosis.
Topics: Ascites; Diagnosis, Differential; Humans; Liver Cirrhosis; Paracentesis; Prognosis; Recurrence
PubMed: 15920323
DOI: 10.1159/000084723 -
Revista Espanola de Enfermedades... Oct 2020Paracentesis is a common and well accepted technique for its diagnostic-therapeutic profitability. This procedure is considered rapid, minimally invasive and safe, but...
Paracentesis is a common and well accepted technique for its diagnostic-therapeutic profitability. This procedure is considered rapid, minimally invasive and safe, but we must not forget that it can lead to severe complications. In this letter we present two patients with hemorrhagic complications following paracentesis. Both cases were treated by percutaneous transarterial embolization. Likewise, in the absence of consensus on the prevention of complications and on their optimal management, we make some recommendations.
Topics: Embolization, Therapeutic; Humans; Paracentesis
PubMed: 32954781
DOI: 10.17235/reed.2020.6914/2020 -
Digestive Diseases (Basel, Switzerland) 2005Spontaneous bacterial peritonitis (SBP) is a bacterial infection of ascitic fluid in patients with decompensated cirrhosis. The modifier 'spontaneous' distinguishes this... (Review)
Review
Spontaneous bacterial peritonitis (SBP) is a bacterial infection of ascitic fluid in patients with decompensated cirrhosis. The modifier 'spontaneous' distinguishes this from surgical peritonitis. The infecting organisms are usually enteric gram-negatives which have translocated from the bowel. Symptoms of infection occur in most patients with SBP, including fever, abdominal pain, mental status changes, and ileus. A high index of suspicion should exist for SBP in patients with cirrhosis and ascites. Diagnostic abdominal paracentesis can be undertaken with minimal risk and should be performed in all patients admitted to the hospital, during times of worsening clinical appearance, or when gastrointestinal bleeding occurs. The ascitic fluid polymorphonuclear cell count is the most sensitive test in evaluating for infection. Cultures of the ascitic fluid are helpful in identifying the organism and are best performed by bedside injection of blood culture bottles. Ascites total protein, lactate dehydrogenase, and glucose levels can assist in distinguishing SBP from secondary peritonitis. Empirical therapy is recommended after paracentesis if suspicion for infection exists. Cefotaxime is the best-studied antibiotic for this purpose and has excellent penetration into ascites with no nephrotoxicity. Prophylaxis should be limited to high-risk settings. Mortality rates in SBP have declined dramatically, largely due to earlier detection and improved therapy.
Topics: Anti-Bacterial Agents; Ascites; Gram-Negative Bacterial Infections; Humans; Liver Cirrhosis; Paracentesis; Peritonitis; Prognosis
PubMed: 15920324
DOI: 10.1159/000084724 -
Ugeskrift For Laeger May 2014
Topics: Contraindications, Procedure; Exudates and Transudates; Humans; Paracentesis; Pleural Effusion
PubMed: 25351901
DOI: No ID Found