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RecruitingNCT06179368Updated Jan 16, 2024

Throid Dysfunction in Liver Failure and Its Eddects Upon Outcome

An observational study in Hepatic Encephalopathy, Hepatic Impairment and Hypothyroidism, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-01-16.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hepatic Encephalopathy
  • Hepatic Impairment
  • Hypothyroidism
  • Hepatic Failure

Keywords

  • Hepatic Failure
  • Hypothyroidism
03

In context

Hepatic Encephalopathy

225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 58 observational studies indexed under Hepatic Encephalopathy.

Browse Hepatic Encephalopathy studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • hepatic fauiure patients

Exclusion criteria

Exclusion Criteria:

  • hypethyroid patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Hypothroid group

    throid fuction will be evaluated on admission of hepatic failure patients, and the hypothroid patients will be enroled in this group.

    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.

    Diagnostic Test: euothyroid

Interventions

  • Diagnostic testhypothroidism

    throid fuction will be evaluated on admission of hepatic failure patients, and the hypothyroid patients will be enroled in this group.

  • Diagnostic testeuothyroid

    throid fuction will be evaluated on admission of hepatic failure patients, and the euothyroid patients will be enroled in this group.

06

What researchers measure

Primary outcomes

  1. short termoutcome

    mortality during hospitalstay

    Time frame: (0 to 30 days)

Secondary outcomes

  1. complications

    suchas renal affection, bleeding tendency ...etc

    Time frame: (0 to 30 days)

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 30294575 ↗
  • McCormick 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 data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Apr 2024, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2023
First posted
Dec 21, 2023
StartActual
Jan 1, 2024
Primary completionEst.
Apr 1, 2024
CompletionEst.
May 1, 2024
Last update
Jan 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06179368
Lead sponsor
Assiut University
Responsible party
Emad Zarief , MD (professor, Assiut University) — Principal investigator
First posted
Dec 21, 2023
Start date
Jan 1, 2024
Primary completion
Apr 1, 2024 (estimated)
Completion
May 1, 2024 (estimated)
Last update
Jan 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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