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Renal DysfunctionNCT06772909

Prevalence Of Renal Dysfunction In Patients With Chronic Liver Disease Admitted To Sohag University Hospital

An observational study of Renal Dysfunction, run by Sohag University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To find out the prevalence of renal dysfunction in chronic liver disease patients who admitted to sohag university hospital Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Renal Dysfunction
How many people
150 participants
Where
No sites listed yet
Study dates
Jan 2025to Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: prevalence of renal dysfunction in chronic liver disease patients who admitted to sohag university hospital

Who may be able to join

  • Data regarding demographic variables (age, weight, sex),
  • Evidence for chronic liver disease is defined by:
  • A compatible Clinical profile (signs of liver cell failure or reduced liver span) along with Biochemical (altered liver function tests, reversal of albumin globulin ratio, etc) or Sonographic evidence (altered echotexture of the liver) Diuretics will be withheld for 3 days before carrying out lab investigations.

Who cannot join

  • • patients >70 years
  • Known primary renal disease or obstructive uropathy
  • Diabetes mellitus
  • Hypertension

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Reham Hossam Mohamed Ahmed contact

+201098190338

reham_hossam_post@med.sohag.edu.eg

Amal Khalifa Ahmed noureldin contact

About this study

To find out the prevalence of renal dysfunction in chronic liver disease patients who admitted to sohag university hospital

Read the detailed description

The interrelationship between liver disease and renal dysfunction was recognized as early as the era of Hippocrates and this has been the object of a considerable amount of research since then. Kidney dysfunction in liver disease can be due to different etiologies and can have diverse manifestations. Most of the abnormalities of kidney function in cirrhosis are of functional origin- namely, sodium retention, impaired free water excretion, and renal vasoconstriction with a decrease in renal perfusion and glomerular filtration rate.

Renal dysfunction in chronic liver disease usually follows a progressive course - the final phase being Hepatorenal syndrome (HRS).

There is no explanation that fully defines the complex relationship between the diseased liver and disturbances in kidney function, though substantial progress is being made in recent years regarding research in this aspect. One of the most difficult issues in the clinical evaluation of patients with cirrhosis is the accurate assessment of renal function. Standard measures of renal function like blood urea nitrogen and serum creatinine are likely to give erroneous impressions and hence alternative methods to determine renal reserve must be used.

Kidney function is evaluated by assessing the glomerular filtration rate (GFR) For many years now, the assessment of GFR has relied on the measurement of the concentration of serum creatinine, which is associated with many problems. Creatinine is a product of the metabolism of creatine, produced in the liver from three amino acids, methionine, arginine, and glycine, and stored in muscle to be used as a source of energy once phosphorylated. Creatinine does not appear in the plasma at a constant rate; it is secreted in the tubule and can undergo extrarenal elimination, thought to involve creatinase in the gut. Serum creatinine concentration displays an exponential relationship with GFR, rendering it specific, but not a sensitive measure of GFR. The creatinine pool is affected by gender, age, ethnicity, nutritional state, protein intake, and importantly liver disease. 1 In chronic liver disease, the reduction in the serum creatinine pool is due to a 50% decrease in hepatic production of creatine; increases in the volume of distribution due to the accumulation of extracellular fluid, edema, and ascites; malnutrition and loss of muscle mass, which is related to repeated episodes of sepsis and large-volume ascites affecting satiety.2 Ultimately, patients with chronic liver disease have a significantly lower baseline serum creatinine concentration than the general population (35-75 μmol/l).

Patients with chronic liver disease display smaller and delayed (up to 48-72 hours) changes in serum creatinine for a given change in GFR, thus impairing the recognition and underestimating the degree of change in GFR.3,4 Detection of renal insufficiency is clinically important because it contributes significantly to high morbidity and mortality in cirrhosis. Moreover, renal dysfunction is one of the most important risk factors when liver transplantation is being considered. Patients with cirrhosis and renal failure are at high risk for death while awaiting transplantation and have an increased frequency of complications and reduced survival after transplantation, as compared with those without renal failure.

Being tested
No intervention (observational study)
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention (observational study)Other

    no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prevalence of renal dysfunction in patients with chronic liver disease

    prevalence of renal dysfunction in patients with chronic liver disease

    Measured: during admission time at sohag university hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study startJan 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06772909
Sponsor's protocol ID
Soh-Med--24-12-10MS
Status last verified
Jan 2025
First submitted
2 Jan 2025
Last updated
14 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Dysfunction, run by Sohag University.

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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 Jan 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reham Hossam Mohamed Ahmed (+201098190338, reham_hossam_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prevalence of renal dysfunction in patients with chronic liver disease (time frame: during admission time at sohag university hospital). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Jan 2025.

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