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.
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.
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.
- Conditions
- Renal Dysfunction
- 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.
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.
- First posted14 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DysfunctionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Hossam Mohamed, Sohag University
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Of Renal Dysfunction In Patients With Chronic Liver Disease Admitted To Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06772909
- Acronym / sponsor ID
- Soh-Med--24-12-10MS
- Conditions
- Renal Dysfunction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Jan 2025 (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.
To find out the prevalence of renal dysfunction in chronic liver disease patients who admitted to sohag university hospital
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- prevalence of renal dysfunction in chronic liver disease patients who admitted to sohag university hospital
Key inclusion criteria (3 listed)
- Data regarding demographic variables (age, weight, sex),
- 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.
Key exclusion criteria (4 listed)
- • patients >70 years
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 |
|---|---|---|
| No intervention (observational study)no intervention | Other | – |
Primary outcome
prevalence of renal dysfunction in patients with chronic liver disease
Time frame: during admission time at sohag university hospital
prevalence of renal dysfunction in patients with chronic liver disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Amal Khalifa Ahmed noureldin contact
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.