Liver CirrhosisNCT05082064
Observational Prospective Study.at the End of the Study the Patients Will be Classified According to PH,Serum Bicarbonate and Serum Sodium Into 6 Groups and Statistical Analysis Will be Performed Using Spss
An observational study of Liver Cirrhosis, run by Sohag University at 1 site in Egypt.
Trial summary
1-to identify the prognostic value of serum bicarbonate and serum electrolytes at time of admission and their association with development of complications ,length of hospital stay ,prognosis and mortality in hospitalized cirrhotic patient Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- arterial blood gases and serum electrolytes
- How many people
- 121 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Oct 2021to 7 Jan 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the study protocol will be approved by ethical committee of sohag university of medicine written informed consent will be obtained from all participants
Who may be able to join
- patients with confirmed diagnosis of cirrhosis (age >18 years ) who will be admitted to internal medicine department or will be admitted to intermediate care unit
- willing and agree to be included in the study
Who cannot join
- patients without evidence of cirrhosis
- cirrhotic patients whom -younger than 18 years old
- have diabetic ketoacidosis
- with acute coronary syndrome
- with fulminant liver failure
- with heart failure
Show all 10Show fewer
- with organ transplantation
- when arterial blood gases not be available
- patient refusal
- patient with HCC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Serum Bicarbonate and Electrolytes on Adverse Outcomes in Decompensated Cirrhotic Patients in Sohag University Hospital
1-to identify the prognostic value of serum bicarbonate and serum electrolytes at time of admission and their association with development of complications ,length of hospital stay ,prognosis and mortality in hospitalized cirrhotic patient
Read the detailed description
the purpose of this study will be explore the impact of data obtained for the arterial blood gas parameters and serum bicarbonate and electrolytes at the time of hospital admission on adverse clinical outcomes ,duration of length of hospital stay and mortality in patients with cirrhosis .Furthermore incorporation these parameters into model of end stage liver disease could help to improve the prognostic value of MELDscore in comparison to the prognostic value of traditional equation of original MELD and child score
- Conditions
- Liver Cirrhosis
- Being tested
- arterial blood gases and serum electrolytes
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial blood gases and serum electrolytesDiagnostic test
arterial bloog gases parameters serum potassium serum sodium serum calcium
| Study group | Role | What they receive |
|---|---|---|
| MELD score group A | MELD score :group A<25 Receives: Diagnostic Test: arterial blood gases and serum electrolytes | |
| MELD group B | Group B>25 Receives: Diagnostic Test: arterial blood gases and serum electrolytes | |
| MELD-PACO2 Group C | Group C<25 Receives: Diagnostic Test: arterial blood gases and serum electrolytes | |
| MELD -PACO2 Group D | Group D>25 Receives: Diagnostic Test: arterial blood gases and serum electrolytes | |
| MELD-BICARBONATE score Group E | Group E<23 Receives: Diagnostic Test: arterial blood gases and serum electrolytes | |
| MELD-BICARBONATE Group F | Group F>23 Receives: Diagnostic Test: arterial blood gases and serum electrolytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
will be ICU admitted
will be admitted to ICU due to progression of the disease
complications as shok,hepatorenal syndrome,severe infection,starting renal replacement therapy and icu intervention as mechanical ventilation using MELD score and child score depending on ABGparameters and serum electrolytes .
Measured: from the day of admission to the day of discharge from hospital or death during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start8 Oct 2021
- Primary completion8 Dec 2022
- Study completion7 Jan 2023
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 CirrhosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Allah Fadel Abdel Rahman, Sohag University
- Investigators
- Heba allah Fadel, Doctor, Principal investigator, Clinical trial organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082064
- Sponsor's protocol ID
- liver cirrhosis
- Status last verified
- Jan 2023
- First submitted
- 10 Sep 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Scheiner B, Lindner G, Reiberger T, Schneeweiss B, Trauner M, Zauner C, Funk GC. Acid-base disorders in liver disease. J Hepatol. 2017 Nov;67(5):1062-1073. doi: 10.1016/j.jhep.2017.06.023. Epub 2017 Jul 3.
PubMed 28684104
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serum Bicarbonate and Electrolytes on Adverse Outcomes in Decompensated Cirrhotic Patients in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05082064
- Acronym / sponsor ID
- liver cirrhosis
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 7 Jan 2023 (actual)
- First posted
- 18 Oct 2021 (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.
1-to identify the prognostic value of serum bicarbonate and serum electrolytes at time of admission and their association with development of complications ,length of hospital stay ,prognosis and mortality in hospitalized cirrhotic patient
Detailed description
the purpose of this study will be explore the impact of data obtained for the arterial blood gas parameters and serum bicarbonate and electrolytes at the time of hospital admission on adverse clinical outcomes ,duration of length of hospital stay and mortality in patients with cirrhosis .Furthermore incorporation these parameters into model of end stage liver disease could help to improve the prognostic value of MELDscore in comparison to the prognostic value of traditional equation of original MELD and child score
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MELD score group A | – | Diagnostic Test: arterial blood gases and serum electrolytesMELD score :group A<25 |
| MELD group B | – | Diagnostic Test: arterial blood gases and serum electrolytesGroup B>25 |
| MELD-PACO2 Group C | – | Diagnostic Test: arterial blood gases and serum electrolytesGroup C<25 |
| MELD -PACO2 Group D | – | Diagnostic Test: arterial blood gases and serum electrolytesGroup D>25 |
| MELD-BICARBONATE score Group E | – | Diagnostic Test: arterial blood gases and serum electrolytesGroup E<23 |
| MELD-BICARBONATE Group F | – | Diagnostic Test: arterial blood gases and serum electrolytesGroup F>23 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the study protocol will be approved by ethical committee of sohag university of medicine written informed consent will be obtained from all participants
Key inclusion criteria (2 listed)
- patients with confirmed diagnosis of cirrhosis (age >18 years ) who will be admitted to internal medicine department or will be admitted to intermediate care unit
- willing and agree to be included in the study
Key exclusion criteria (10 listed)
- patients without evidence of cirrhosis
- cirrhotic patients whom -younger than 18 years old
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 |
|---|---|---|
| arterial blood gases and serum electrolytesarterial bloog gases parameters serum potassium serum sodium serum calcium | Diagnostic test | MELD -PACO2 Group D, MELD group B, MELD score group A, MELD-BICARBONATE Group F, MELD-BICARBONATE score Group E, MELD-PACO2 Group C |
Primary outcome
will be ICU admitted
Time frame: from the day of admission to the day of discharge from hospital or death during hospitalization
will be admitted to ICU due to progression of the disease complications as shok,hepatorenal syndrome,severe infection,starting renal replacement therapy and icu intervention as mechanical ventilation using MELD score and child score depending on ABGparameters and serum electrolytes .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Results publication: PubMed 28684104Scheiner B, Lindner G, Reiberger T, Schneeweiss B, Trauner M, Zauner C, Funk GC. Acid-base disorders in liver disease. J Hepatol. 2017 Nov;67(5):1062-1073. doi: 10.1016/j.jhep.2017.06.023. Epub 2017 Jul 3.
- 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. This study is not recruiting at the moment.
Heba allah Fadel, Doctor principal investigator
Clinical trial organization
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 Liver Cirrhosis, run by Sohag 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 10 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
will be ICU admitted (time frame: from the day of admission to the day of discharge from hospital or death during hospitalization). 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 NCT05082064, 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 10 Jan 2023.