Liver CirrhosesNCT04242979
Assessing of Physicians' Knowledge About International Guidelines of Albumin Use in Patients With Liver Cirrhosis
A study testing Questionnaire about albumin use in liver cirrhosis in people with Liver Cirrhoses, run by Abdelrahman Salah Eldin Abodief.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 years and older
- Conditions the study is for
- Liver Cirrhoses
- What is being tested?
- Questionnaire about albumin use in liver cirrhosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non gastroenterology physicians
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Liver Cirrhoses
- Being tested
- Questionnaire about albumin use in liver cirrhosis
- Keywords
- Albumin use in liver cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire about albumin use in liver cirrhosisBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaire about albumin use in liver cirrhosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month
Secondary outcomes (1)
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)
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdelrahman Salah Eldin Abodief
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrahman Salah Eldin Abodief, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242979
- Sponsor's protocol ID
- HA use in liver cirrhosis
- Status last verified
- Jan 2020
- First submitted
- 11 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29611452
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing of Physicians' Knowledge About International Guidelines of Albumin Use in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04242979
- Acronym / sponsor ID
- HA use in liver cirrhosis
- Conditions
- Liver Cirrhoses
- Keywords
- Albumin use in liver cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Abdelrahman Salah Eldin AbodiefUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Human albumin use in liver cirrhosis | Other | Behavioral: Questionnaire about albumin use in liver cirrhosisEach 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. |
Who may qualify
- Ages
- 26 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Non gastroenterology physicians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire about albumin use in liver cirrhosis1. 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 | Behavioural | Human albumin use in liver cirrhosis |
Primary outcome
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 secondary outcome
Questionnaire
Time frame: 2-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 29611452Caraceni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire about albumin use in liver cirrhosis in people with Liver Cirrhoses, run by Abdelrahman Salah Eldin Abodief.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Salah Abodief, MBBCh (01003447486, abodief.zeid1234@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.