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

NCT ID: NCT05220891

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2024-02-11

Brief 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.

Detailed 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).

Conditions

Ascites

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Paracentesis

Intervention Type: OTHER

Paracentesis from ascitic patient

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.

Paracentesis

Intervention Type: OTHER

Paracentesis from ascitic patient

Interventions

Paracentesis

Paracentesis from ascitic patient

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shady Ashraf Kassem

OTHER

Sponsor Role: lead

Responsible Party

Shady Ashraf Kassem

Resident

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Shady Elsedfy, Resident

Role: CONTACT

elsdfyshady@gmail.com

01028790280

References

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.

Reference Type: BACKGROUND

PMID: 31849085 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 29749656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19278163 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 19479632 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25995329 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 31806129 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19475696 (View on PubMed)

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.

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Other Identifiers

Ascitis control

Identifier Type: -

Identifier Source: org_study_id