Sodium Status in Septic Patients and Its Relation to Prognosis an Hospital Stay

January 11, 2021 updated by: Kareem Sherif, Assiut University

Evaluation of Sodium Status in Septic and Septic Shock Patients and Its Relation to Prognosis and Hospital Stay

The aim of the present study is to identify the prevalence and prognostic impact of sodium imbalance on sepsis and septic shock patients

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Sepsis and septic shock are among the most prevalent causes of intensive care unit (ICU) admissions. They account for around 10-50% of the mortality rate, which remains high despite extensive research of the Surviving Sepsis Campaign, and national core measures Sepsis is defined as "Organ dysfunction that threatens the patient's life caused by the impaired host response to infection" septic shock is defined as hypotension and serum lactate level greater than two mmol/L, as well as not responding to adequate fluid resuscitation requiring the use of vasopressors to maintain the mean blood pressure of 65 mm Hg or higher . Sepsis and septic shock are considered medical emergencies .

Acute hypernatremia is considered one of the features of homeostasis disturbances, which is common in septic patients with an incidence reaching up to 47% Finding biomarkers which predict the outcome of sepsis is challenging . Since electrolyte imbalance, specifically hypernatremia, is one of the commonest problems associated with sepsis and septic shock patients [20, 21]. It is, therefore, of current interest to study the evolution of sepsis in patients who have been shown to have hypernatremia.

Recent evidence shows that serum sodium levels may not be completely explained by fluid balance or sodium intake . Some studies suggest that sodium is intimately tied to the immune system, thus raising the question of whether inflammatory states such as sepsis can play a role in the development of hypernatremia

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmed Mohamed Obeid Allah, Assistant professor
  • Phone Number: 01007556396

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Septic and septic shock patients admitted to the ICU to evaluate their sodium status

Description

Inclusion Criteria:

The diagnosis of sepsis and septic shock was made prior to the ICU admission. Sepsis and septic shock were defined according to the 3 definition using the Quick Sofa score of 2 or more

Sepsis : 2 or more of the SIRS criteria :

  • Temperature >38 or <36 c
  • Heart Rate >90 beats/minute
  • Respiratory rate >20 cycle /minute
  • wbc >20,000 or < 4,000 Plus the presumed existence of infection
  • Blood pressure can be normal Septic shock : the same as sepsis plus refractory hypotension
  • After bolus of 20- 40 ml/kg patient has one of the following :

    • SBP >90 mm Hg
    • MAP <65 mm Hg
    • Decrease of 40 mm Hg of base line hypernatremia [Na+]> 145 mmol/L eunatremia [135-145]mmol/l hyponatremia <135 mmol/L

Exclusion Criteria:

patients under the age of 18 years patients with a previous diagnosis of hyperaldosteronism patints diagnosed with Cushing syndrome, patients diagnosed with diabetes insipidus.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sodium level disorders in Sepsis
Time Frame: Baseline
Correlation between sodium level disorders in septic and septic shock patients and the outcome represented by ICU mortality and ICU length stay
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this 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 (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Sodium level in septic patient

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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