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Assessing of Physicians' Knowledge About International Guidelines of Albumin Use in Patients With Liver Cirrhosis

Primary Purpose

Liver Cirrhoses

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Questionnaire about albumin use in liver cirrhosis
Sponsored by
Abdelrahman Salah Eldin Abodief
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Liver Cirrhoses focused on measuring Albumin use in liver cirrhosis

Eligibility Criteria

26 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Gastroenterology physicians in:

  • Al-Rajhi Liver Hospital (Tropical Medicine Department, and Internal Medicine, GIT Unit).
  • Police Hospital.
  • Health Insurance Hospital.
  • Assiut Center for Management of HCV.
  • El - Shamla Hospital.
  • Al-Eman Hospital.

Exclusion Criteria:

  • Non gastroenterology physicians

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Human albumin use in liver cirrhosis

    Arm Description

    Each participant involved in the study will be assessed for his or her knowledge using (tool I). 5-Data will be collected by personal interview with participants or via fulfilling online questionnaire taking in consideration data confidentiality. 6-Application of the designed evidence based indications for human albumin use supported by the international guidelines will be done by researcher using (tool II). 7-Evaluate the effect of the designed evidence based indications for human albumin use supported by the international guidelines on physicians' knowledge after 1 month using (tool I) in a random sample of those physicians.

    Outcomes

    Primary Outcome Measures

    Questionnaire
    The investigators will know physicians' basic mean knowledge score about human albumin use in validated and non validated indications. The score will be from (0-2)

    Secondary Outcome Measures

    Questionnaire
    The investigators will determine the effect of designed evidence based indication for human albumin use supported by the international guidelines on mean knowledge scores of physicians.The score will be from (0-2)

    Full Information

    First Posted
    January 11, 2020
    Last Updated
    January 24, 2020
    Sponsor
    Abdelrahman Salah Eldin Abodief
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04242979
    Brief Title
    Assessing of Physicians' Knowledge About International Guidelines of Albumin Use in Patients With Liver Cirrhosis
    Official Title
    Assessing of Physicians' Knowledge About International Guidelines of Albumin Use in Patients With Liver Cirrhosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2020 (Anticipated)
    Primary Completion Date
    April 1, 2022 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Abdelrahman Salah Eldin Abodief

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Due to shortage of local studies of the adherence of physicians to the guidelines for albumin use among patients with liver cirrhosis so this study aims to assess: Physicians' knowledge on the evidence-based indications for HA use supported by the international guidelines; Whether HA is used in clinical conditions not supported by solid scientific evidence; To formulate the evidence-based indications for HA use supported by the international guidelines and to evaluate effect of distributing these evidence-based indications on physicians' knowledge.
    Detailed Description
    In the last part of the previous century the increasing knowledge about the cardiovascular abnormalities that occur in advanced cirrhosis led researchers to design prospective randomized clinical trials assessing the effect of exogenous human albumin (HA) based on its well-established capacity to act as plasma-expander. Due to the positive results reported by those studies, international guidelines have included the administration of HA among the recommendations for the prevention of post-paracentesis circulatory dysfunction (PPCD) or renal failure induced by spontaneous bacterial peritonitis (SBP), and for the diagnosis and treatment of hepatorenal syndrome (HRS) . Indeed, all these complications are characterized by a substantial reduction of effective volemia. However, even in these settings, questions regarding HA dosage and whether or not all patients should be treated remain unanswered . It has now become evident that circulatory dysfunction and organ damage in patients with decompensated cirrhosis are related to a chronic state of systemic inflammation and oxidative stress, which can abruptly exacerbate in patients developing acute-on-chronic liver failure (ACLF), a syndrome characterized by extra-hepatic organ failure and poor short-term survival. Besides colloid-osmotic power, HA is provided with many biological properties unrelated to the regulation of fluid compartmentalization. Among these, some would assume particular importance in relation to the inflammatory state of decompensated cirrhosis, such as antioxidant and scavenging activities, binding and transport of many endogenous and exogenous substances, and regulation of endothelial function and inflammatory/immunological response . Therefore, due to both its oncotic and non-oncotic properties, HA may exert beneficial effects at different steps of the cascade of the pathogenetic events that link circulatory dysfunction to systemic inflammation, providing a novel pathophysiological perspective for the use of HA. In this regard, two nationwide surveys on the use of HA in patients with cirrhosis conducted in the United States and France aiming to assess the adherence to the current AASLD and EASL guidelines respectively, have shown that HA is also prescribed besides the evidence-based indications. Indeed, HA is not rarely employed in non-SBP bacterial infections, severe hyponatremia, and hypoalbuminemia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Cirrhoses
    Keywords
    Albumin use in liver cirrhosis

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Tool (I): An interview questionnaire(in English) sheet for the physicians will be carried out evaluating : the use of albumin in validated indications. the prescriptions of albumin for non validated clinical situations. TOOL (II): Designed evidence-based indications for HA use supported by the international guidelines. It includes general information about albumin prescription, mechanism of action of albumin in liver cirrhosis, prevention of PPCD, prevention of renal failure after SBP, diagnosis of HRS, treatment of HRS, other potential clinical indication for albumin.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Human albumin use in liver cirrhosis
    Arm Type
    Other
    Arm Description
    Each participant involved in the study will be assessed for his or her knowledge using (tool I). 5-Data will be collected by personal interview with participants or via fulfilling online questionnaire taking in consideration data confidentiality. 6-Application of the designed evidence based indications for human albumin use supported by the international guidelines will be done by researcher using (tool II). 7-Evaluate the effect of the designed evidence based indications for human albumin use supported by the international guidelines on physicians' knowledge after 1 month using (tool I) in a random sample of those physicians.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Questionnaire about albumin use in liver cirrhosis
    Intervention Description
    Permission to carry out the study will be obtained from the Faculty's Ethics Committee. To achieve validity and reliability of the tool. It will be reviewed by two experts in the field of the study and necessary modification will be done. A pilot study will be 10% done to test the clarity and feasibility of developed tool. Each participant involved in the study will be assessed for his or her knowledge using (tool I). Data will be collected by personal interview with participants or via fulfilling online questionnaire taking in consideration data confidentiality. Application of the designed evidence based indications for human albumin use supported by the international guidelines will be done by researcher using (tool II). Evaluate the effect of the designed evidence based indications for human albumin use supported by the international guidelines on physicians' knowledge after 1 month using (tool I) in a random sample of those physicians
    Primary Outcome Measure Information:
    Title
    Questionnaire
    Description
    The investigators will know physicians' basic mean knowledge score about human albumin use in validated and non validated indications. The score will be from (0-2)
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Questionnaire
    Description
    The investigators will determine the effect of designed evidence based indication for human albumin use supported by the international guidelines on mean knowledge scores of physicians.The score will be from (0-2)
    Time Frame
    2-3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    26 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Gastroenterology physicians in: Al-Rajhi Liver Hospital (Tropical Medicine Department, and Internal Medicine, GIT Unit). Police Hospital. Health Insurance Hospital. Assiut Center for Management of HCV. El - Shamla Hospital. Al-Eman Hospital. Exclusion Criteria: Non gastroenterology physicians
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdelrahman Salah Abodief, MBBCh
    Phone
    01003447486
    Email
    abodief.zeid1234@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ehab Fawzy Moustafa, Professor
    Phone
    01016154222
    Email
    Ehabmostafa99@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29611452
    Citation
    Caraceni P, Pavesi M, Baldassarre M, Bernardi M, Arroyo V. The use of human albumin in patients with cirrhosis: a European survey. Expert Rev Gastroenterol Hepatol. 2018 Jun;12(6):625-632. doi: 10.1080/17474124.2018.1460203. Epub 2018 Apr 4.
    Results Reference
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    Assessing of Physicians' Knowledge About International Guidelines of Albumin Use in Patients With Liver Cirrhosis

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