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

  • Egypt
      • Sohag, Egypt
        • Heba Allah fadel abd elrahman

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
Diagnostic test: arterial blood gases and serum electrolytes
arterial bloog gases parameters serum potassium serum sodium serum calcium
MELD group B
Group B>25
Diagnostic test: arterial blood gases and serum electrolytes
arterial bloog gases parameters serum potassium serum sodium serum calcium
MELD-PACO2 Group C
Group C<25
Diagnostic test: arterial blood gases and serum electrolytes
arterial bloog gases parameters serum potassium serum sodium serum calcium
MELD -PACO2 Group D
Group D>25
Diagnostic test: arterial blood gases and serum electrolytes
arterial bloog gases parameters serum potassium serum sodium serum calcium
MELD-BICARBONATE score Group E
Group E<23
Diagnostic test: arterial blood gases and serum electrolytes
arterial bloog gases parameters serum potassium serum sodium serum calcium
MELD-BICARBONATE Group F
Group F>23
Diagnostic test: arterial blood gases and serum electrolytes
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

Sohag University

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.

General Publications

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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