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

NCT05082064 | Completed

• 1 other identifier: liver cirrhosis
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 .

  from the day of admission to the day of discharge from hospital or death during hospitalization

Study Arms (6)

MELD score group A

MELD score :group A\<25

Diagnostic Test: arterial blood gases and serum electrolytes

MELD group B

Group B\>25

Diagnostic Test: arterial blood gases and serum electrolytes

MELD-PACO2 Group C

Group C\<25

Diagnostic Test: arterial blood gases and serum electrolytes

MELD -PACO2 Group D

Group D\>25

Diagnostic Test: arterial blood gases and serum electrolytes

MELD-BICARBONATE score Group E

Group E\<23

Diagnostic Test: arterial blood gases and serum electrolytes

MELD-BICARBONATE Group F

Group F\>23

Diagnostic Test: arterial blood gases and serum electrolytes

Interventions

arterial blood gases and serum electrolytes DIAGNOSTIC_TEST

arterial bloog gases parameters serum potassium serum sodium serum calcium

MELD -PACO2 Group D; MELD group B; MELD score group A; MELD-BICARBONATE Group F; MELD-BICARBONATE score Group E; MELD-PACO2 Group C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Heba Allah fadel abd elrahman

Sohag, Egypt

Location

Related Publications (1)

• 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.

  PMID: 28684104 RESULT

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Heba allah Fadel, Doctor

  Clinical trial organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor,principle investigator

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 18, 2021
• Study Start: October 8, 2021
• Primary Completion: December 8, 2022
• Study Completion: January 7, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

EG (1)