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
January 7, 2023 updated by: Heba Allah Fadel Abdel Rahman, Sohag University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
121
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sohag, Egypt
- Heba Allah fadel abd elrahman
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
- with organ transplantation
- when arterial blood gases not be available
- patient refusal
- patient with HCC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
MELD score group A
MELD score :group A<25
|
arterial bloog gases parameters serum potassium serum sodium serum calcium
|
|
MELD group B
Group B>25
|
arterial bloog gases parameters serum potassium serum sodium serum calcium
|
|
MELD-PACO2 Group C
Group C<25
|
arterial bloog gases parameters serum potassium serum sodium serum calcium
|
|
MELD -PACO2 Group D
Group D>25
|
arterial bloog gases parameters serum potassium serum sodium serum calcium
|
|
MELD-BICARBONATE score Group E
Group E<23
|
arterial bloog gases parameters serum potassium serum sodium serum calcium
|
|
MELD-BICARBONATE Group F
Group F>23
|
arterial bloog gases parameters serum potassium serum sodium serum calcium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 . |
from the day of admission to the day of discharge from hospital or death during hospitalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heba allah Fadel, Doctor, Clinical trial organization
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 8, 2021
Primary Completion (Actual)
December 8, 2022
Study Completion (Actual)
January 7, 2023
Study Registration Dates
First Submitted
September 10, 2021
First Submitted That Met QC Criteria
October 5, 2021
First Posted (Actual)
October 18, 2021
Study Record Updates
Last Update Posted (Estimate)
January 10, 2023
Last Update Submitted That Met QC Criteria
January 7, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- liver cirrhosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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