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

January 24, 2020 updated by: Abdelrahman Salah Eldin Abodief

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abdelrahman Salah Eldin Abodief

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

January 11, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA use in liver cirrhosis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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