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2.2 Aim(s) of the Research (50 words max):
To Compare between crystalloid and colloid I.V fluid therapy in the prevention of paracentesis induced circulatory dysfunction (PICD) and renal dysfunction in patients with decompensated liver cirrhosis in Egypt.
To evaluate systemic vascular resistance in cirrhotic patients with tense ascites before and after therapeutic paracentesis.
Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work). (200-250 words max.)
In the advanced stages of cirrhosis, there is pronounced arterial vasodilatation that further worsens by therapeutic paracentesis which plays a major role in causing circulatory dysfunction (El-Motey et al. 2013). Paracentesis-induced circulatory dysfunction (PICD) in cirrhotics with tense ascites develops in the majority of patients not receiving plasma volume expansion (Hamdy et al.,2014). Paracentesis induced circulatory dysfunction (PICD) will induce pronounced arterial vasodilatation in cirrhotic patients with tense ascites which can be prevented by the infusion of albumin, (Arora et al.,2020). albumin infusion is highly effective in preventing this disorder. However, albumin substitution is costly and holds the theoretical risk of infectious complications and allergic reactions (Arora et al.,2020). Various vasoconstrictors have also been used to prevent PICD such as terlipressin and noradrenaline. However, terlipressin is expensive and not available in some countries, and the use of noradrenaline requires intravenous (IV) infusion and intense monitoring (Singh et al .,2006), but there are few studies about the usage of crystalloids (Arora et al.,2020).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crystalloid group | Group( 1)Patients will be randomly assigned to be treated with crystalloid (n=30). They will receive an intravenous infusion of saline at a constant rate utilizing a pump infusion device (170 mL of 3.5% saline solution per liter of ascites removed at 999 mL/h). The amount of liquid infused and rate of infusion was selected based on previous studies (Sola-vera et al.,2003) Group (2)Patients will be randomly assigned to be treated with colloid (n=30). Albumin will be given at a dose of 8 g/L of ascitic fluid removed and will be infused immediately during the process of paracentesis. After paracentesis, diuretics and plasma expanders will be withheld until hospital discharge. |
| |
| Colloid group | Group (2)Patients will be randomly assigned to be treated with colloid (n=30). Albumin will be given at a dose of 8 g/L of ascitic fluid removed and will be infused immediately during the process of paracentesis. After paracentesis, diuretics and plasma expanders will be withheld until hospital discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracentesis | Other | Paracentesis from ascitic patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Paracentesis enduced circulatory dysfunction | The primary endpoint will be taken as the development of PICD. PICD will be defined as a significant drop in systemic vascular resistance before and after paracentesis using paired t-test with P-value < 0.05. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Paracentesis induced renal impairment | Secondary (subsidiary): The secondary endpoint will be taken as the development of renal impairment or hyponatremia. Renal impairment will be defined as an increase in serum creatinine before and after paracentesis using paired t-test with P-value < 0.05. Hyponatremia is defined as a decrease in serum sodium >5mEq/L, to a level <130 mEq/L; in patients with a serum sodium concentration of <130 mEq/ L before treatment, hyponatremia will be defined as a decrease in serum sodium of >5mEq/L after paracentesi |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be randomly divided into two groups:
Group( 1)Patients will be randomly assigned to be treated with crystalloid (n=30). They will receive an intravenous infusion of saline at a constant rate utilizing a pump infusion device (170 mL of 3.5% saline solution per liter of ascites removed at 999 mL/h). The amount of liquid infused and rate of infusion was selected based on previous studies (Sola-vera et al.,2003) Group (2)Patients will be randomly assigned to be treated with colloid (n=30). Albumin will be given at a dose of 8 g/L of ascitic fluid removed and will be infused immediately during the process of paracentesis.
After paracentesis, diuretics and plasma expanders will be withheld until hospital discharge.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shady Elsedfy, Resident | Contact | 01028790280 | elsdfyshady@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31849085 | Background | Arora V, Vijayaraghavan R, Maiwall R, Sahney A, Thomas SS, Ali R, Jain P, Kumar G, Sarin SK. Paracentesis-Induced Circulatory Dysfunction With Modest-Volume Paracentesis Is Partly Ameliorated by Albumin Infusion in Acute-on-Chronic Liver Failure. Hepatology. 2020 Sep;72(3):1043-1055. doi: 10.1002/hep.31071. Epub 2020 Jul 9. | |
| 29749656 |
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| Baseline |
| Darnis E, Boysen S, Merveille AC, Desquilbet L, Chalhoub S, Gommeren K. Establishment of reference values of the caudal vena cava by fast-ultrasonography through different views in healthy dogs. J Vet Intern Med. 2018 Jul;32(4):1308-1318. doi: 10.1111/jvim.15136. Epub 2018 May 10. |
| 19278163 | Background | Richert A, Raines D, Lopez FA. New onset ascites secondary to cirrhosis. J La State Med Soc. 2009 Jan-Feb;161(1):9-13; quiz 13, 54. No abstract available. |
| 19479632 | Background | Moller S, Henriksen JH, Bendtsen F. Ascites: pathogenesis and therapeutic principles. Scand J Gastroenterol. 2009;44(8):902-11. doi: 10.1080/00365520902912555. |
| 29243322 | Background | Novo Matos J, Pereira N, Glaus T, Wilkie L, Borgeat K, Loureiro J, Silva J, Law V, Kranjc A, Connolly DJ, Luis Fuentes V. Transient Myocardial Thickening in Cats Associated with Heart Failure. J Vet Intern Med. 2018 Jan;32(1):48-56. doi: 10.1111/jvim.14897. Epub 2017 Dec 15. |
| 25995329 | Background | Marwick TH, Gillebert TC, Aurigemma G, Chirinos J, Derumeaux G, Galderisi M, Gottdiener J, Haluska B, Ofili E, Segers P, Senior R, Tapp RJ, Zamorano JL. Recommendations on the use of echocardiography in adult hypertension: a report from the European Association of Cardiovascular Imaging (EACVI) and the American Society of Echocardiography (ASE)dagger. Eur Heart J Cardiovasc Imaging. 2015 Jun;16(6):577-605. doi: 10.1093/ehjci/jev076. |
| 16460491 | Background | Singh V, Kumar R, Nain CK, Singh B, Sharma AK. Terlipressin versus albumin in paracentesis-induced circulatory dysfunction in cirrhosis: a randomized study. J Gastroenterol Hepatol. 2006 Jan;21(1 Pt 2):303-7. doi: 10.1111/j.1440-1746.2006.04182.x. |
| 31806129 | Background | Shah AM, Cikes M, Prasad N, Li G, Getchevski S, Claggett B, Rizkala A, Lukashevich I, O'Meara E, Ryan JJ, Shah SJ, Mullens W, Zile MR, Lam CSP, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Echocardiographic Features of Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction. J Am Coll Cardiol. 2019 Dec 10;74(23):2858-2873. doi: 10.1016/j.jacc.2019.09.063. |
| 19475696 | Background | Runyon BA; AASLD Practice Guidelines Committee. Management of adult patients with ascites due to cirrhosis: an update. Hepatology. 2009 Jun;49(6):2087-107. doi: 10.1002/hep.22853. No abstract available. |
| 12717396 | Background | Sola-Vera J, Minana J, Ricart E, Planella M, Gonzalez B, Torras X, Rodriguez J, Such J, Pascual S, Soriano G, Perez-Mateo M, Guarner C. Randomized trial comparing albumin and saline in the prevention of paracentesis-induced circulatory dysfunction in cirrhotic patients with ascites. Hepatology. 2003 May;37(5):1147-53. doi: 10.1053/jhep.2003.50169. |
| ID | Term |
|---|---|
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019152 | Paracentesis |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004322 | Drainage |
| D013812 | Therapeutics |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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