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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242979
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Salah Eldin Abodief, Assiut University

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:

  1. Physicians' knowledge on the evidence-based indications for HA use supported by the international guidelines;
  2. Whether HA is used in clinical conditions not supported by solid scientific evidence;
  3. 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.

Condition or disease Intervention/treatment Phase
Liver Cirrhoses Behavioral: Questionnaire about albumin use in liver cirrhosis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Tool (I):

An interview questionnaire(in English) sheet for the physicians will be carried out evaluating :

  1. the use of albumin in validated indications.
  2. 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)
Primary Purpose: Screening
Official Title: Assessing of Physicians' Knowledge About International Guidelines of Albumin Use in Patients With Liver Cirrhosis
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Human albumin use in liver cirrhosis

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.

Behavioral: Questionnaire about albumin use in liver cirrhosis
  1. Permission to carry out the study will be obtained from the Faculty's Ethics Committee.
  2. 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.
  3. A pilot study will be 10% done to test the clarity and feasibility of developed tool.
  4. 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




Primary Outcome Measures :
  1. Questionnaire [ Time Frame: 1 month ]

    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 :
  1. Questionnaire [ Time Frame: 2-3 years ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   26 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242979


Contacts
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Contact: Abdelrahman Salah Abodief, MBBCh 01003447486 abodief.zeid1234@gmail.com
Contact: Ehab Fawzy Moustafa, Professor 01016154222 Ehabmostafa99@yahoo.com

Sponsors and Collaborators
Abdelrahman Salah Eldin Abodief
Publications:
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Responsible Party: Abdelrahman Salah Eldin Abodief, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04242979    
Other Study ID Numbers: HA use in liver cirrhosis
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdelrahman Salah Eldin Abodief, Assiut University:
Albumin use in liver cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases