Clinical Trial: High‐dose furosemide plus small‐volume hypertonic saline solutions vs. repeated paracentesis as treatment of refractory ascites

Summary Background In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy. Aim To compare the safety and efficacy of intravenous high‐dose furosemide + hypertonic saline solutions (HSS) with repeated paracentesis in pat...

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Published in	Alimentary pharmacology & therapeutics Vol. 30; no. 3; pp. 227 - 235
Main Authors	LICATA, G., TUTTOLOMONDO, A., LICATA, A., PARRINELLO, G., DI RAIMONDO, D., DI SCIACCA, R., CAMMÀ, C., CRAXÌ, A., PATERNA, S., PINTO, A.
Format	Journal Article
Language	English
Published	Oxford, UK Blackwell Publishing Ltd 01.08.2009 Blackwell
Subjects	Abdomen Adult Aged Aged, 80 and over Ascites - etiology Ascites - therapy Biological and medical sciences Digestive system Diuretics - therapeutic use Dose-Response Relationship, Drug Female Furosemide - administration & dosage Gastroenterology. Liver. Pancreas. Abdomen Humans Liver Cirrhosis - complications Liver Cirrhosis - physiopathology Liver Cirrhosis - therapy Male Medical sciences Middle Aged Other diseases. Semiology Paracentesis Pharmacology. Drug treatments Pilot Projects Saline Solution, Hypertonic - administration & dosage Treatment Outcome Human Treatment resistance Effusion Furosemide Diuretic Treatment Sulfonamides Abdominal disease Anthranilic acid derivatives Antihypertensive agent Clinical trial Ascites High dose Hypertonic solution Saline solution Comparative study Paracentesis
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Abstract	Summary Background In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy. Aim To compare the safety and efficacy of intravenous high‐dose furosemide + hypertonic saline solutions (HSS) with repeated paracentesis in patients with cirrhosis and refractory ascites. Patients and methods Eighty‐four subjects (59/25 M/F) with cirrhosis, mostly of viral aetiology, admitted for refractory ascites, were randomly assigned to receive furosemide (250–1000 mg/bid i.v.) plus HSS (150 mL H2O with NaCl 1.4–4.6% or 239–187 mEq/L) (60 patients, Group A) or to repeated paracentesis and a standard diuretic schedule (24 patients, Group B). Results During hospitalization, Group A patients had more diuresis (1605 ± 131 mL vs. 532 ± 124 mL than Group B patients; P < 0.001) and a greater loss of weight at discharge (−8.8 ± 4.8 kg vs. −4.5 ± 3.8 kg, P < 0.00). Control of ascites, pleural effusions and/or leg oedema was deemed significantly better in Group A. Conclusions This randomized pilot study suggests that HHS plus high‐dose furosemide is a safe and effective alternative to repeated paracentesis when treating hospitalized patients with cirrhosis and refractory ascites. Larger studies will be needed to evaluate long‐term outcomes such as readmission and mortality.
AbstractList	In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy. To compare the safety and efficacy of intravenous high-dose furosemide + hypertonic saline solutions (HSS) with repeated paracentesis in patients with cirrhosis and refractory ascites. Eighty-four subjects (59/25 M/F) with cirrhosis, mostly of viral aetiology, admitted for refractory ascites, were randomly assigned to receive furosemide (250-1000 mg/bid i.v.) plus HSS (150 mL H(2)O with NaCl 1.4-4.6% or 239-187 mEq/L) (60 patients, Group A) or to repeated paracentesis and a standard diuretic schedule (24 patients, Group B). During hospitalization, Group A patients had more diuresis (1605 +/- 131 mL vs. 532 +/- 124 mL than Group B patients; P < 0.001) and a greater loss of weight at discharge (-8.8 +/- 4.8 kg vs. -4.5 +/- 3.8 kg, P < 0.00). Control of ascites, pleural effusions and/or leg oedema was deemed significantly better in Group A. This randomized pilot study suggests that HHS plus high-dose furosemide is a safe and effective alternative to repeated paracentesis when treating hospitalized patients with cirrhosis and refractory ascites. Larger studies will be needed to evaluate long-term outcomes such as readmission and mortality. In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy.BACKGROUNDIn patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy.To compare the safety and efficacy of intravenous high-dose furosemide + hypertonic saline solutions (HSS) with repeated paracentesis in patients with cirrhosis and refractory ascites.AIMTo compare the safety and efficacy of intravenous high-dose furosemide + hypertonic saline solutions (HSS) with repeated paracentesis in patients with cirrhosis and refractory ascites.Eighty-four subjects (59/25 M/F) with cirrhosis, mostly of viral aetiology, admitted for refractory ascites, were randomly assigned to receive furosemide (250-1000 mg/bid i.v.) plus HSS (150 mL H(2)O with NaCl 1.4-4.6% or 239-187 mEq/L) (60 patients, Group A) or to repeated paracentesis and a standard diuretic schedule (24 patients, Group B).PATIENTS AND METHODSEighty-four subjects (59/25 M/F) with cirrhosis, mostly of viral aetiology, admitted for refractory ascites, were randomly assigned to receive furosemide (250-1000 mg/bid i.v.) plus HSS (150 mL H(2)O with NaCl 1.4-4.6% or 239-187 mEq/L) (60 patients, Group A) or to repeated paracentesis and a standard diuretic schedule (24 patients, Group B).During hospitalization, Group A patients had more diuresis (1605 +/- 131 mL vs. 532 +/- 124 mL than Group B patients; P < 0.001) and a greater loss of weight at discharge (-8.8 +/- 4.8 kg vs. -4.5 +/- 3.8 kg, P < 0.00). Control of ascites, pleural effusions and/or leg oedema was deemed significantly better in Group A.RESULTSDuring hospitalization, Group A patients had more diuresis (1605 +/- 131 mL vs. 532 +/- 124 mL than Group B patients; P < 0.001) and a greater loss of weight at discharge (-8.8 +/- 4.8 kg vs. -4.5 +/- 3.8 kg, P < 0.00). Control of ascites, pleural effusions and/or leg oedema was deemed significantly better in Group A.This randomized pilot study suggests that HHS plus high-dose furosemide is a safe and effective alternative to repeated paracentesis when treating hospitalized patients with cirrhosis and refractory ascites. Larger studies will be needed to evaluate long-term outcomes such as readmission and mortality.CONCLUSIONSThis randomized pilot study suggests that HHS plus high-dose furosemide is a safe and effective alternative to repeated paracentesis when treating hospitalized patients with cirrhosis and refractory ascites. Larger studies will be needed to evaluate long-term outcomes such as readmission and mortality. SummaryBackground In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy.Aim To compare the safety and efficacy of intravenous high-dose furosemide + hypertonic saline solutions (HSS) with repeated paracentesis in patients with cirrhosis and refractory ascites.Patients and methods Eighty-four subjects (59-25 M-F) with cirrhosis, mostly of viral aetiology, admitted for refractory ascites, were randomly assigned to receive furosemide (250-1000 mg-bid i.v.) plus HSS (150 mL H2O with NaCl 1.4-4.6% or 239-187 mEq-L) (60 patients, Group A) or to repeated paracentesis and a standard diuretic schedule (24 patients, Group B).Results During hospitalization, Group A patients had more diuresis (1605 c 131 mL vs. 532 c 124 mL than Group B patients; P < 0.001) and a greater loss of weight at discharge (-8.8 c 4.8 kg vs. -4.5 c 3.8 kg, P < 0.00). Control of ascites, pleural effusions and-or leg oedema was deemed significantly better in Group A.Conclusions This randomized pilot study suggests that HHS plus high-dose furosemide is a safe and effective alternative to repeated paracentesis when treating hospitalized patients with cirrhosis and refractory ascites. Larger studies will be needed to evaluate long-term outcomes such as readmission and mortality. Background In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy. Aim To compare the safety and efficacy of intravenous high‐dose furosemide + hypertonic saline solutions (HSS) with repeated paracentesis in patients with cirrhosis and refractory ascites. Patients and methods Eighty‐four subjects (59/25 M/F) with cirrhosis, mostly of viral aetiology, admitted for refractory ascites, were randomly assigned to receive furosemide (250–1000 mg/bid i.v.) plus HSS (150 mL H 2 O with NaCl 1.4–4.6% or 239–187 mEq/L) (60 patients, Group A) or to repeated paracentesis and a standard diuretic schedule (24 patients, Group B). Results During hospitalization, Group A patients had more diuresis (1605 ± 131 mL vs. 532 ± 124 mL than Group B patients; P < 0.001) and a greater loss of weight at discharge (−8.8 ± 4.8 kg vs. −4.5 ± 3.8 kg, P < 0.00). Control of ascites, pleural effusions and/or leg oedema was deemed significantly better in Group A. Conclusions This randomized pilot study suggests that HHS plus high‐dose furosemide is a safe and effective alternative to repeated paracentesis when treating hospitalized patients with cirrhosis and refractory ascites. Larger studies will be needed to evaluate long‐term outcomes such as readmission and mortality. Summary Background In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy. Aim To compare the safety and efficacy of intravenous high‐dose furosemide + hypertonic saline solutions (HSS) with repeated paracentesis in patients with cirrhosis and refractory ascites. Patients and methods Eighty‐four subjects (59/25 M/F) with cirrhosis, mostly of viral aetiology, admitted for refractory ascites, were randomly assigned to receive furosemide (250–1000 mg/bid i.v.) plus HSS (150 mL H2O with NaCl 1.4–4.6% or 239–187 mEq/L) (60 patients, Group A) or to repeated paracentesis and a standard diuretic schedule (24 patients, Group B). Results During hospitalization, Group A patients had more diuresis (1605 ± 131 mL vs. 532 ± 124 mL than Group B patients; P < 0.001) and a greater loss of weight at discharge (−8.8 ± 4.8 kg vs. −4.5 ± 3.8 kg, P < 0.00). Control of ascites, pleural effusions and/or leg oedema was deemed significantly better in Group A. Conclusions This randomized pilot study suggests that HHS plus high‐dose furosemide is a safe and effective alternative to repeated paracentesis when treating hospitalized patients with cirrhosis and refractory ascites. Larger studies will be needed to evaluate long‐term outcomes such as readmission and mortality.
Author	CAMMÀ, C. PINTO, A. PARRINELLO, G. DI RAIMONDO, D. DI SCIACCA, R. PATERNA, S. LICATA, G. TUTTOLOMONDO, A. LICATA, A. CRAXÌ, A.
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Keywords	Human Treatment resistance Effusion Furosemide Diuretic Treatment Sulfonamides Abdominal disease Anthranilic acid derivatives Antihypertensive agent Clinical trial Ascites High dose Hypertonic solution Saline solution Comparative study Paracentesis
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Snippet	Summary Background In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy. Aim ... Background In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy. Aim To... In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy. To compare the safety... SummaryBackground In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy.Aim To... In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy.BACKGROUNDIn patients...
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SubjectTerms	Abdomen Adult Aged Aged, 80 and over Ascites - etiology Ascites - therapy Biological and medical sciences Digestive system Diuretics - therapeutic use Dose-Response Relationship, Drug Female Furosemide - administration & dosage Gastroenterology. Liver. Pancreas. Abdomen Humans Liver Cirrhosis - complications Liver Cirrhosis - physiopathology Liver Cirrhosis - therapy Male Medical sciences Middle Aged Other diseases. Semiology Paracentesis Pharmacology. Drug treatments Pilot Projects Saline Solution, Hypertonic - administration & dosage Treatment Outcome
Title	Clinical Trial: High‐dose furosemide plus small‐volume hypertonic saline solutions vs. repeated paracentesis as treatment of refractory ascites
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