- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04564508
Sodium Status in Septic Patients and Its Relation to Prognosis an Hospital Stay
Evaluation of Sodium Status in Septic and Septic Shock Patients and Its Relation to Prognosis and Hospital Stay
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Kareem Sherif, Resident doctor
- Phone Number: 01002447880
- Email: kareemsherif14@gmail.com
Study Contact Backup
- Name: Ahmed Mohamed Obeid Allah, Assistant professor
- Phone Number: 01007556396
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Sodium level in septic patient
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