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

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05082064

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis	Diagnostic Test: arterial blood gases and serum electrolytes

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

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Serum Bicarbonate and Electrolytes on Adverse Outcomes in Decompensated Cirrhotic Patients in Sohag University Hospital

Anticipated Study Start Date :

Oct 8, 2021

Anticipated Primary Completion Date :

Mar 8, 2022

Anticipated Study Completion Date :

Mar 8, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

will be ICU admitted [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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sohag University

Investigators

Principal Investigator: Heba allah Fadel, Doctor, Clinical trial organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heba Allah Fadel Abdel Rahman, doctor,principle investigator, Sohag University

ClinicalTrials.gov Identifier:

NCT05082064

Other Study ID Numbers:

liver cirrhosis

First Posted:

Oct 18, 2021

Last Update Posted:

Oct 18, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Cirrhosis

Study Results

No Results Posted as of Oct 18, 2021