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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

S

Shady Ashraf Kassem

Status

Unknown

Conditions

Ascites

Treatments

Other: Paracentesis

Study type

Observational

Funder types

Other

Identifiers

NCT05220891
Ascitis control

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Crystalloid group
Description:
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.
Treatment:
Other: Paracentesis
Colloid group
Description:
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.
Treatment:
Other: Paracentesis

Trial contacts and locations

0

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Central trial contact

Shady Elsedfy, Resident

Data sourced from clinicaltrials.gov

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