Comparison of Crystalloid and Colloid I.V Fluid Therapy in Prevention of Paracentesis Induced Circulatory Dysfunction (PICD) and Renal Dysfunction in Patients With Decompensated Liver Cirrhosis in Egypt: a Randomized Piolet Study

Ascites Clinical Trial

Official title:

Comparison of Crystalloid and Colloid I.V Fluid Therapy in Prevention of Paracentesis Induced Circulatory Dysfunction (PICD) and Renal Dysfunction in Patients With Decompensated Liver Cirrhosis in Egypt: a Randomized Piolet Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05220891
• Other study ID #: Ascitis control
• Status: Not yet recruiting
• Start date: January 11, 2023
• Est. completion date: February 11, 2024

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: Shady Elsedfy, Resident
• Phone: 01028790280
• Email: elsdfyshady[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients less than 70 years of age and more than 18 years, diagnosed as having liver cirrhosis with tense refractory ascites (> 5 liters). These diagnoses are determined by clinical, biochemical, morphological, and sonographic criteria.

Exclusion Criteria:

• Patients with blood pressure < 90/60 mmHg, and or HR > 110 b/m Patients with heart disease, pulmonary disease, alcohol consumption, pregnancy, hepatorenal syndrome Patients with hepatic encephalopathy, hepatorenal syndrome, or recent GIT haemorrage in last week Patients with spontaneous bacterial peritonitis or sepsis. Prothrombin time less than 30%, platelet count less than 30,000/mm3, serum creatinine level greater than 240 mmol/l Patients receiving any drugs that could interfere with cardiovascular, hepatic, or renal function, however, the use of diuretics and/or beta-blockers were permitted, but they were temporarily discontinued for 2 days before the investigations to eliminate the pharmacological influence on systemic vascular resistance work or volume status

Related Conditions & MeSH terms

• Ascites
• Liver Cirrhosis
• Renal Insufficiency

Intervention

Other:
• Paracentesis
Paracentesis from ascitic patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shady Ashraf Kassem

References & Publications (10)

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. — View Citation

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. — View Citation

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)†. Eur Heart J Cardiovasc Imaging. 2015 Jun;16(6):577-605. doi: 10.1093/ehjci/jev076. Review. — View Citation

Møller S, Henriksen JH, Bendtsen F. Ascites: pathogenesis and therapeutic principles. Scand J Gastroenterol. 2009;44(8):902-11. doi: 10.1080/00365520902912555. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sola-Vera J, Miñana J, Ricart E, Planella M, González B, Torras X, Rodríguez J, Such J, Pascual S, Soriano G, Pérez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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	Baseline