Effects of Adding Hypertonic Saline Solutions and/or Etilefrine to Standard Diuretics Therapy in Hepatic Ascites
NCT ID: NCT04785755
Last Updated: 2021-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2017-11-30
2020-04-30
Brief Summary
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Detailed Description
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Patients were randomized into four groups:
Group I: (n=15) received oral standard diuretic therapy (furosemide 40 mg plus spironolactone 100 mg with dose increase in 40 mg :100 mg ratio).
Group II: (n=25) received (150 ml,1.4% - 4.6%) of hypertonic saline solution (HSS) plus standard diuretics therapy.
Group III: (n=25) received etilefrine 5 mg tablets 3 times daily plus standard diuretics therapy.
Group IV: (n=25) received (150 ml, 1.4% - 4.6%) of HSS and etilefrine 5 mg tablets 3 times daily plus standard diuretics therapy.
Time frame:
Oral standard diuretics therapy administered for 38 days. Etilefrine tablets administered for 38 days. Infusion of HSS administered for eight days. Diuretics dosage reassessed according to blood pressure, diuresis, serum sodium, and serum potassium levels.
All blood and urine samples were collected and measured as follows:
1. At baseline before initiation of any treatment (first measurement)
2. Eight days after treatment with studied medications (second measurement).
3. One month after the second measurement (third measurement).
Samples collection:
Venous blood samples were drawn from enrolled patients in the morning before treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement). Blood samples were centrifuged and the resulting supernatant was frozen at -80 C until all samples were collected. 24-hr urine was collected in the morning from 7 am to 7 am of the next day before initiation of treatment, after eight days of treatment, and after a month from the second measurement to assess diuresis and urinary creatinine, urinary Na, and urinary K, also hepatic and renal functions, complete blood count, serum levels of c-reactive protein, interleukin-6, aldosterone, and leptin were measured at baseline, after eight days and, after a month from the second measurement.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group I
The control group (n=15) received oral standard diuretic therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
Oral standard diuretics therapy
Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
Group II
The hypertonic saline solution (HSS) group (n=25) received oral standard diuretic therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the start of the study to the end of the study) with hypertonic saline solution (150ml, 1.4% - 4.6%) infused slowly over one hour peripherally once daily from the first day of the study for eight days.
Oral standard diuretics therapy
Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
Hypertonic saline solution
Hypertonic saline solution (150ml, 1.4% - 4.6%) infused slowly over one hour peripherally once daily from the first day of the study for eight days.
Group III
The etilefrine group (n=25) received oral standard diuretic therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study), and etilefrine 5 mg tablet given by mouth three times daily for 38 days (from the first day of the study to the end of the study).
Oral standard diuretics therapy
Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
Etilefrine
Etilefrine 5 mg tablet given by mouth three times daily for 38 days (from the first day of the study to the end of the study).
Group IV
The hypertonic saline solution (HSS) + Etilefrine group (n=25) received oral standard diuretic therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg100mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study), with hypertonic saline solution (150ml, 1.4% - 4.6%) infused slowly over one hour peripherally once daily from the first day of the study for eight days, and etilefrine 5 mg tablet given by mouth three times daily for 38 days (from the first day of the study to the end of the study).
Oral standard diuretics therapy
Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
Hypertonic saline solution
Hypertonic saline solution (150ml, 1.4% - 4.6%) infused slowly over one hour peripherally once daily from the first day of the study for eight days.
Etilefrine
Etilefrine 5 mg tablet given by mouth three times daily for 38 days (from the first day of the study to the end of the study).
Interventions
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Oral standard diuretics therapy
Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
Hypertonic saline solution
Hypertonic saline solution (150ml, 1.4% - 4.6%) infused slowly over one hour peripherally once daily from the first day of the study for eight days.
Etilefrine
Etilefrine 5 mg tablet given by mouth three times daily for 38 days (from the first day of the study to the end of the study).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients ages from 25 -65 years.
Exclusion Criteria
* Congestive heart failure.
* Acute renal failure.
* Hepatocellular carcinoma.
* All Cancer types.
* Arterial hypertension.
* Acute infection.
25 Years
65 Years
ALL
No
Sponsors
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Hala Abd EL-Tawab Ibrahim Radwan
OTHER
Responsible Party
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Hala Abd EL-Tawab Ibrahim Radwan
clinical pharmacy master degree, pharm D
Principal Investigators
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Gamal A Badra, professor
Role: STUDY_DIRECTOR
national liver institute / menoufiya university
Sahar El-Haggar, professor
Role: STUDY_DIRECTOR
Tanta University
hala El said, professor
Role: STUDY_DIRECTOR
national liver institute / menoufiya university
Locations
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National liver institute- menoufiya university
Shibīn al Kawm, Monufia Governorate, Egypt
Countries
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References
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Gu XB, Yang XJ, Zhu HY, Xu BY. Effect of a diet with unrestricted sodium on ascites in patients with hepatic cirrhosis. Gut Liver. 2012 Jul;6(3):355-61. doi: 10.5009/gnl.2012.6.3.355. Epub 2012 Jul 12.
Morando F, Rosi S, Gola E, Nardi M, Piano S, Fasolato S, Stanco M, Cavallin M, Romano A, Sticca A, Caregaro L, Gatta A, Angeli P. Adherence to a moderate sodium restriction diet in outpatients with cirrhosis and ascites: a real-life cross-sectional study. Liver Int. 2015 May;35(5):1508-15. doi: 10.1111/liv.12583. Epub 2014 May 21.
Sam J, Nguyen GC. Protein-calorie malnutrition as a prognostic indicator of mortality among patients hospitalized with cirrhosis and portal hypertension. Liver Int. 2009 Oct;29(9):1396-402. doi: 10.1111/j.1478-3231.2009.02077.x. Epub 2009 Jul 7.
Eghtesad S, Poustchi H, Malekzadeh R. Malnutrition in liver cirrhosis:the influence of protein and sodium. Middle East J Dig Dis. 2013 Apr;5(2):65-75.
Arroyo V, Fernandez J. Relationship between systemic hemodynamics, renal dysfunction, and fluid retention in cirrhosis. Clin Liver Dis (Hoboken). 2013 Jun 21;2(3):120-122. doi: 10.1002/cld.185. eCollection 2013 Jun. No abstract available.
Guo TT, Yang Y, Song Y, Ren Y, Liu ZX, Cheng G. Effects of midodrine in patients with ascites due to cirrhosis: Systematic review and meta-analysis. J Dig Dis. 2016 Jan;17(1):11-9. doi: 10.1111/1751-2980.12304.
Singh V, Dhungana SP, Singh B, Vijayverghia R, Nain CK, Sharma N, Bhalla A, Gupta PK. Midodrine in patients with cirrhosis and refractory or recurrent ascites: a randomized pilot study. J Hepatol. 2012 Feb;56(2):348-54. doi: 10.1016/j.jhep.2011.04.027. Epub 2011 Jul 13.
Hatanaka E, Shimomi FM, Curi R, Campa A. Sodium chloride inhibits cytokine production by lipopolysaccharide-stimulated human neutrophils and mononuclear cells. Shock. 2007 Jan;27(1):32-5. doi: 10.1097/01.shk.0000238061.69579.a5.
Kolsen-Petersen JA. Immune effect of hypertonic saline: fact or fiction? Acta Anaesthesiol Scand. 2004 Jul;48(6):667-78. doi: 10.1111/j.1399-6576.2004.00396.x.
Perez-Perez A, Vilarino-Garcia T, Fernandez-Riejos P, Martin-Gonzalez J, Segura-Egea JJ, Sanchez-Margalet V. Role of leptin as a link between metabolism and the immune system. Cytokine Growth Factor Rev. 2017 Jun;35:71-84. doi: 10.1016/j.cytogfr.2017.03.001. Epub 2017 Mar 4.
Buechler C, Haberl EM, Rein-Fischboeck L, Aslanidis C. Adipokines in Liver Cirrhosis. Int J Mol Sci. 2017 Jun 29;18(7):1392. doi: 10.3390/ijms18071392.
Reynolds TB, Lieberman FL, Goodman AR. Advantages of treatment of ascites without sodium restriction and without complete removal of excess fluid. Gut. 1978 Jun;19(6):549-53. doi: 10.1136/gut.19.6.549.
Lafreniere G, Beliveau P, Begin JY, Simonyan D, Cote S, Gaudreault V, Israeli Z, Lavi S, Bagur R. Effects of hypertonic saline solution on body weight and serum creatinine in patients with acute decompensated heart failure. World J Cardiol. 2017 Aug 26;9(8):685-692. doi: 10.4330/wjc.v9.i8.685.
Henriksen JH, Fuglsang S, Bendtsen F, Moller S. Arterial hypertension in cirrhosis: arterial compliance, volume distribution, and central haemodynamics. Gut. 2006 Mar;55(3):380-7. doi: 10.1136/gut.2005.064329.
Li H, Guo Z, Yang X, Sun D. Mean arterial pressure drop is an independent risk factor of death in patients with HBV-related cirrhosis ascites. Turk J Gastroenterol. 2017 Jan;28(1):26-30. doi: 10.5152/tjg.2016.0412. Epub 2016 Dec 19.
Drazner MH, Palmer BF. Hypertonic saline: a novel therapy for advanced heart failure? Am Heart J. 2003 Mar;145(3):377-9. doi: 10.1067/mhj.2003.165. No abstract available.
Tuttolomondo A, Di Raimondo D, Bellia C, Clemente G, Pecoraro R, Maida C, Simonetta I, Vassallo V, Di Bona D, Gulotta E, Ciaccio M, Pinto A. Immune-Inflammatory and Metabolic Effects of High Dose Furosemide plus Hypertonic Saline Solution (HSS) Treatment in Cirrhotic Subjects with Refractory Ascites. PLoS One. 2016 Dec 12;11(12):e0165443. doi: 10.1371/journal.pone.0165443. eCollection 2016.
Okuhara Y, Hirotani S, Naito Y, Nakabo A, Iwasaku T, Eguchi A, Morisawa D, Ando T, Sawada H, Manabe E, Masuyama T. Intravenous salt supplementation with low-dose furosemide for treatment of acute decompensated heart failure. J Card Fail. 2014 May;20(5):295-301. doi: 10.1016/j.cardfail.2014.01.012. Epub 2014 Jan 22.
Haberl J, Zollner G, Fickert P, Stadlbauer V. To salt or not to salt?-That is the question in cirrhosis. Liver Int. 2018 Jul;38(7):1148-1159. doi: 10.1111/liv.13750. Epub 2018 May 16.
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Gauthier A, Levy VG, Quinton A, Michel H, Rueff B, Descos L, Durbec JP, Fermanian J, Lancrenon S. Salt or no salt in the treatment of cirrhotic ascites: a randomised study. Gut. 1986 Jun;27(6):705-9. doi: 10.1136/gut.27.6.705.
Other Identifiers
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ascites of liver cirrhosis
Identifier Type: -
Identifier Source: org_study_id
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