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

NCT05220891 | Unknown

• 1 other identifier: Ascitis control
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ascites

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Paracentesis induced renal impairment

  Baseline

Study Arms (2)

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.

Other: Paracentesis

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.

Other: Paracentesis

Interventions

Paracentesis OTHER

Paracentesis from ascitic patient

Colloid group; Crystalloid group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shady Ashraf Kassem: lead

Related 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.

  PMID: 31849085 BACKGROUND

• 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.

  PMID: 29749656 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.

  PMID: 19278163 BACKGROUND

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

  PMID: 19479632 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.

  PMID: 29243322 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.

  PMID: 25995329 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.

  PMID: 16460491 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.

  PMID: 31806129 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.

  PMID: 19475696 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.

  PMID: 12717396 BACKGROUND

MeSH Terms

Conditions

Ascites

Interventions

Paracentesis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drainage; Therapeutics; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Shady Elsedfy, Resident

CONTACT

01028790280; elsdfyshady@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: February 2, 2022
• Study Start: January 11, 2023
• Primary Completion: January 11, 2024
• Study Completion: February 11, 2024
• Last Updated: February 2, 2022

Record last verified: 2022-01