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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Ascites

Intervention / Treatment
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* Other: Paracentesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crystalloid group<br>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. | Other: Paracentesis<br>* Paracentesis from ascitic patient<br>|
| Colloid group<br>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. | Other: Paracentesis<br>* Paracentesis from ascitic patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Baseline |