Sodium DisorderNCT04564508
Sodium Status in Septic Patients and Its Relation to Prognosis an Hospital Stay
An observational study of Sodium Disorder, run by Assiut University.
Trial summary
The aim of the present study is to identify the prevalence and prognostic impact of sodium imbalance on sepsis and septic shock patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sodium Disorder
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Septic and septic shock patients admitted to the ICU to evaluate their sodium status
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- patients under the age of 18 years patients with a previous diagnosis of hyperaldosteronism patints diagnosed with Cushing syndrome, patients diagnosed with diabetes insipidus.
Trial locations and contacts
No sites are listed yet.
Ahmed Mohamed Obeid Allah, Assistant professor contact
About this study
Official title: 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
Read the 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
- Conditions
- Sodium Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium level disorders in Sepsis
Correlation between sodium level disorders in septic and septic shock patients and the outcome represented by ICU mortality and ICU length stay
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Jan 2021 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Sherif, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564508
- Sponsor's protocol ID
- Sodium level in septic patient
- Status last verified
- Jan 2021
- First submitted
- 21 Sep 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sodium Status in Septic and Septic Shock Patients and Its Relation to Prognosis and Hospital Stay
- ClinicalTrials.gov ID
- NCT04564508
- Acronym / sponsor ID
- Sodium level in septic patient
- Conditions
- Sodium Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to identify the prevalence and prognostic impact of sodium imbalance on sepsis and septic shock patients
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Septic and septic shock patients admitted to the ICU to evaluate their sodium status
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- patients under the age of 18 years patients with a previous diagnosis of hyperaldosteronism patints diagnosed with Cushing syndrome, patients diagnosed with diabetes insipidus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
Related trials for Sodium Disorder
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
RecruitingPhase 3
Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
RecruitingEarly Phase 1
Aprepitant for the Treatment of CLIFAHDD
CLIFAHDD, Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mohamed Obeid Allah, Assistant professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Sodium Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kareem Sherif, Resident doctor (01002447880, kareemsherif14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sodium level disorders in Sepsis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.