NCT04242979

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 11, 2020

Last Update Submit

January 24, 2020

Conditions

Keywords

Albumin use in liver cirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 month

Secondary Outcomes (1)

  • Questionnaire

    2-3 years

Study Arms (1)

Human albumin use in liver cirrhosis

OTHER

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

Interventions

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

Human albumin use in liver cirrhosis

Eligibility Criteria

Age26 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Non gastroenterology physicians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29611452BACKGROUND

Central Study Contacts

Abdelrahman Salah Abodief, MBBCh

CONTACT

Ehab Fawzy Moustafa, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2020

First Posted

January 27, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2023

Last Updated

January 27, 2020

Record last verified: 2020-01