Hepatic EncephalopathyNCT06179368
Throid Dysfunction in Liver Failure and Its Eddects Upon Outcome
An observational study of Hepatic Encephalopathy and Hepatic Impairment, run by Assiut University at 1 site in Egypt.
Trial summary
Liver plays an important role in the metabolism of thyroid hormones, as it is the most important organ in the peripheral conversion of tetraiodothyronine (T4) to triiodothyronine (T3) by Type 1 deiodinase. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatic Encephalopathy, Hepatic Impairment, Hypothyroidism
- What is being tested?
- hypothroidism and euothyroid
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 May 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Adult
Study population: all hepatic failutre patients who will be admitted to ICU will be enrolled, and throid function will be assessed. Groupingwil be done based upon throid function
Who may be able to join
- hepatic fauiure patients
Who cannot join
- hypethyroid patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Emad Zarief Kamel Said
Asyut, 71111
Emad Z Kamel, M.D., +201007046058, emadzarief@yahoo.com
About this study
Official title: Thyoid Dysfucntion; Does it Affect the Short Term Outcome of Heptic Failure Patiens ?
Liver plays an important role in the metabolism of thyroid hormones, as it is the most important organ in the peripheral conversion of tetraiodothyronine (T4) to triiodothyronine (T3) by Type 1 deiodinase.
Read the detailed description
In clinical terms, cirrhosis is described as are either "compensated" or "decompensated." Decompensation means cirrhosis complicated by one or more of the following features: jaundice, ascites, hepatic encephalopathy (HE), or bleeding varices. Ascites is the usual first sign. Hepatorenal syndrome, hyponatremia, and spontaneous bacterial peritonitis are also features of decompensation, but in these patients, ascites invariably occurs first. Compensated cirrhotic patients have none of these features.
The liver plays an important role in the metabolism of thyroid hormones, as it is the most important organ in the peripheral conversion of tetraiodothyronine (T4) to T3 by Type 1 deiodinase.
T4 and T3 regulate the basal metabolic rate of all cells, including hepatocytes, and thereby modulate hepatic function. The liver metabolizes the THS and regulates their systemic endocrine effects. Thyroid diseases may perturb liver function; liver disease modulates thyroid hormone metabolism; and a variety of systemic diseases affect both the organs.
- Being tested
- hypothroidism, euothyroid
- Keywords
- Hepatic Failure, Hypothyroidism
- Medical subject headings
- Hepatic Encephalopathy, Hypothyroidism, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypothroidismDiagnostic test
throid fuction will be evaluated on admission of hepatic failure patients, and the hypothyroid patients will be enroled in this group.
euothyroidDiagnostic test
throid fuction will be evaluated on admission of hepatic failure patients, and the euothyroid patients will be enroled in this group.
| Study group | Role | What they receive |
|---|---|---|
| Hypothroid group | throid fuction will be evaluated on admission of hepatic failure patients, and the hypothroid patients will be enroled in this group. Receives: Diagnostic Test: hypothroidism | |
| Euthroid group | throid fuction will be evaluated on admission of hepatic failure patients, and the euothroid patients will be enroled in this group. Receives: Diagnostic Test: euothyroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
short termoutcome
mortality during hospitalstay
Measured: (0 to 30 days)
Secondary outcomes (1)
complications
suchas renal affection, bleeding tendency ...etc
Measured: (0 to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Jan 2024
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179368
- Sponsor's protocol ID
- IRB121223
- Status last verified
- Jan 2024
- First submitted
- 12 Dec 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Punekar P, Sharma AK, Jain A. A Study of Thyroid Dysfunction in Cirrhosis of Liver and Correlation with Severity of Liver Disease. Indian J Endocrinol Metab. 2018 Sep-Oct;22(5):645-650. doi: 10.4103/ijem.IJEM_25_18.
PubMed 30294575McCormick PA. Sherlock's Diseases of the Liver and Biliary System Textbook. Hepatic Cirrhosis. In: Dooley JS, Lok AS, Burroughs AK, Heathcote EJ, editors. 12th ed. Ch. 7. UK: Wiley-Blackwell, A John Wiley and Sons, Ltd; 2011. pp. 103-8.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyoid Dysfucntion; Does it Affect the Short Term Outcome of Heptic Failure Patiens ?
- ClinicalTrials.gov ID
- NCT06179368
- Acronym / sponsor ID
- IRB121223
- Keywords
- Hepatic Failure, Hypothyroidism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 21 Dec 2023 (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.
Liver plays an important role in the metabolism of thyroid hormones, as it is the most important organ in the peripheral conversion of tetraiodothyronine (T4) to triiodothyronine (T3) by Type 1 deiodinase.
Detailed description
In clinical terms, cirrhosis is described as are either "compensated" or "decompensated." Decompensation means cirrhosis complicated by one or more of the following features: jaundice, ascites, hepatic encephalopathy (HE), or bleeding varices. Ascites is the usual first sign. Hepatorenal syndrome, hyponatremia, and spontaneous bacterial peritonitis are also features of decompensation, but in these patients, ascites invariably occurs first. Compensated cirrhotic patients have none of these features.
The liver plays an important role in the metabolism of thyroid hormones, as it is the most important organ in the peripheral conversion of tetraiodothyronine (T4) to T3 by Type 1 deiodinase.
T4 and T3 regulate the basal metabolic rate of all cells, including hepatocytes, and thereby modulate hepatic function. The liver metabolizes the THS and regulates their systemic endocrine effects. Thyroid diseases may perturb liver function; liver disease modulates thyroid hormone metabolism; and a variety of systemic diseases affect both the organs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothroid group | – | Diagnostic Test: hypothroidismthroid fuction will be evaluated on admission of hepatic failure patients, and the hypothroid patients will be enroled in this group. |
| Euthroid group | – | Diagnostic Test: euothyroidthroid fuction will be evaluated on admission of hepatic failure patients, and the euothroid patients will be enroled in this group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- all hepatic failutre patients who will be admitted to ICU will be enrolled, and throid function will be assessed. Groupingwil be done based upon throid function
Key inclusion criteria (1 listed)
- hepatic fauiure patients
Key exclusion criteria (1 listed)
- hypethyroid patients
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 |
|---|---|---|
| hypothroidismthroid fuction will be evaluated on admission of hepatic failure patients, and the hypothyroid patients will be enroled in this group. | Diagnostic test | Hypothroid group |
| euothyroidthroid fuction will be evaluated on admission of hepatic failure patients, and the euothyroid patients will be enroled in this group. | Diagnostic test | Euthroid group |
Primary outcome
short termoutcome
Time frame: (0 to 30 days)
mortality during hospitalstay
1 secondary outcome
complications
Time frame: (0 to 30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Background: PubMed 30294575Punekar P, Sharma AK, Jain A. A Study of Thyroid Dysfunction in Cirrhosis of Liver and Correlation with Severity of Liver Disease. Indian J Endocrinol Metab. 2018 Sep-Oct;22(5):645-650. doi: 10.4103/ijem.IJEM_25_18.
- BackgroundMcCormick PA. Sherlock's Diseases of the Liver and Biliary System Textbook. Hepatic Cirrhosis. In: Dooley JS, Lok AS, Burroughs AK, Heathcote EJ, editors. 12th ed. Ch. 7. UK: Wiley-Blackwell, A John Wiley and Sons, Ltd; 2011. pp. 103-8.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Encephalopathy and Hepatic Impairment, run by Assiut University at 1 site in Egypt.
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 1 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 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short termoutcome (time frame: (0 to 30 days)). 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 NCT06179368, which also lists 2 linked publications.
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 16 Jan 2024.