Sodium BalanceNCT06771869
Comparing Sodium to Fluid Balance in Predicting Respiratory Dysfunction in Critically Ill Septic Patients
An observational study of Sodium Balance, run by Ain Shams University at 1 site in Egypt.
Trial summary
Critically ill septic patients are at risk of positive sodium balance due to inadvertent excess administration, which may be over twice the daily requirement of sodium for healthy individuals This research will estimate sodium balance in critically ill septic patients on invasive mechanical ventilation (MV) for more… Read more about this study
- Who is it for?
- Ages 13 to 70 years
- Conditions the study is for
- Sodium Balance
- What is being tested?
- Sodium balance
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Apr 2025
- 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 13 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: mechanically ventilated septic patients
Who may be able to join
- APACHE II score of more than 12 calculated on admission.
- SOFA score of more than 2 calculated on admission.
- Septic patients who manifested by 2 or more of the following conditions:
- Temperature >38oC or <36oC
- Heart rate >90 beats/min
- Respiratory rate >20 breaths/min or PaCO2 <32mmHg.
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- White blood cell count >12000/mm3, <4000/mm3 or >10% immature (band) forms.
- Mechanically ventilated patients for less than 48 hours and who were anticipated to be on MV for at least another 48 hours.
- Serum sodium concentration between 130 mmol/L and 150 mmol/L
Who cannot join
- Age less than 13 years and more than 70 years.
- Traumatic brain injury.
- ICU admission diagnosis of diabetic ketoacidosis, hyperosmolar hyperglycemic state, Child-Pugh class C liver cirrhosis, pregnancy or anticipated survival of less than 24 hours.
- Patients undergoing renal replacement therapy (RRT).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sodium Balance Rather Than Fluid Balance as a Predictor of Respiratory Dysfunction in Critically Ill Septic Patients on Mechanical Ventilation; a Prospective Observational Study
Critically ill septic patients are at risk of positive sodium balance due to inadvertent excess administration, which may be over twice the daily requirement of sodium for healthy individuals This research will estimate sodium balance in critically ill septic patients on invasive mechanical ventilation (MV) for more than 48 hours and to evaluate the relationship between sodium balance and respiratory function (PaO2/FiO2 ratio) and length of MV
Read the detailed description
This prospective observational cohort study assesses the effect of cumulative positive sodium balance on respiratory function in critically ill septic mechanically ventilated patients Patients admitted to the ICU for 6 months with Age more than 13 yrs. and less than 70 years, an APACHE II score of more than 12 is calculated on admission, and a SOFA score of more than 2 is calculated on admission. Septic patients who manifested by 2 or more of the following conditions: Temperature >38oC or <36oC, Heart rate >90 beats/min, Respiratory rate >20 breaths/min or PaCO2 <32mmHg, White blood cell count >12000/mm3, <4000/mm3 or >10% immature (band) forms, Mechanically ventilated patients for less than 48 hours and who were anticipated to be on MV for at least another 48 hours, Serum sodium concentration between 130 mmol/L and 150 mmol/L will be included in the study.
Data will be collected on the first three days after recruitment, with Day 1 being the day of enrollment. These include the Daily PaO2/FiO2 ratio, Daily urine output, and fluid balance. Routine laboratory investigations include Liver function tests, including ALT, AST, serum bilirubin, and serum albumin. Kidney function tests including serum creatinine and urea level. Complete blood count (CBC). Arterial blood gases. Serum lactate level.
Sodium and fluid intakes will be calculated and recorded for all solutions as the type and volume administered over each 24-hour study day for 3 days.
The primary outcome will be oxygenation (PaO2/FiO2 ratio) and length of MV stay while the Secondary outcomes include Length of ICU and hospital stay, ICU and hospital mortality, and SOFA scores at diagnosis of sepsis, Presence of shock (defined as requirement for vasopressor infusion at any dose for more than 6 hours).
- Labs specific for our study (on ICU admission and if needed):
- Procalcitonin (PCTQ).
- CRP.
- Serum electrolytes: Na, K, Ca
- Conditions
- Sodium Balance
- Being tested
- Sodium balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium balanceDiagnostic test
cumulative sodium balance and cumulative fluid balance will be estimated in the first three days after admission
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated septic patients | Not described Receives: Diagnostic Test: Sodium balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio
Measured: first three days after admission
Secondary outcomes (1)
Length of ICU
Measured: first month after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Sep 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium BalanceStudies of the same condition, open and under way.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771869
- Sponsor's protocol ID
- FMASU MS76/2024
- Status last verified
- Aug 2025
- First submitted
- 8 Jan 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Balance Rather Than Fluid Balance as a Predictor of Respiratory Dysfunction in Critically Ill Septic Patients on Mechanical Ventilation; a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06771869
- Acronym / sponsor ID
- FMASU MS76/2024
- Conditions
- Sodium Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 13 Jan 2025 (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.
Critically ill septic patients are at risk of positive sodium balance due to inadvertent excess administration, which may be over twice the daily requirement of sodium for healthy individuals This research will estimate sodium balance in critically ill septic patients on invasive mechanical ventilation (MV) for more than 48 hours and to evaluate the relationship between sodium balance and respiratory function (PaO2/FiO2 ratio) and length of MV
Detailed description
This prospective observational cohort study assesses the effect of cumulative positive sodium balance on respiratory function in critically ill septic mechanically ventilated patients Patients admitted to the ICU for 6 months with Age more than 13 yrs. and less than 70 years, an APACHE II score of more than 12 is calculated on admission, and a SOFA score of more than 2 is calculated on admission. Septic patients who manifested by 2 or more of the following conditions: Temperature >38oC or <36oC, Heart rate >90 beats/min, Respiratory rate >20 breaths/min or PaCO2 <32mmHg, White blood cell count >12000/mm3, <4000/mm3 or >10% immature (band) forms, Mechanically ventilated patients for less than 48 hours and who were anticipated to be on MV for at least another 48 hours, Serum sodium concentration between 130 mmol/L and 150 mmol/L will be included in the study.
Data will be collected on the first three days after recruitment, with Day 1 being the day of enrollment. These include the Daily PaO2/FiO2 ratio, Daily urine output, and fluid balance. Routine laboratory investigations include Liver function tests, including ALT, AST, serum bilirubin, and serum albumin. Kidney function tests including serum creatinine and urea level. Complete blood count (CBC). Arterial blood gases. Serum lactate level.
Sodium and fluid intakes will be calculated and recorded for all solutions as the type and volume administered over each 24-hour study day for 3 days.
The primary outcome will be oxygenation (PaO2/FiO2 ratio) and length of MV stay while the Secondary outcomes include Length of ICU and hospital stay, ICU and hospital mortality, and SOFA scores at diagnosis of sepsis, Presence of shock (defined as requirement for vasopressor infusion at any dose for more than 6 hours).
- Labs specific for our study (on ICU admission and if needed):
- Procalcitonin (PCTQ).
- CRP.
- Serum electrolytes: Na, K, Ca
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated septic patients | – | Diagnostic Test: Sodium balance |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- mechanically ventilated septic patients
Key inclusion criteria (9 listed)
- APACHE II score of more than 12 calculated on admission.
- SOFA score of more than 2 calculated on admission.
- Septic patients who manifested by 2 or more of the following conditions:
- Mechanically ventilated patients for less than 48 hours and who were anticipated to be on MV for at least another 48 hours.
- Serum sodium concentration between 130 mmol/L and 150 mmol/L
Key exclusion criteria (4 listed)
- Age less than 13 years and more than 70 years.
- Traumatic brain injury.
- ICU admission diagnosis of diabetic ketoacidosis, hyperosmolar hyperglycemic state, Child-Pugh class C liver cirrhosis, pregnancy or anticipated survival of less than 24 hours.
- Patients undergoing renal replacement therapy (RRT).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium balancecumulative sodium balance and cumulative fluid balance will be estimated in the first three days after admission | Diagnostic test | Mechanically ventilated septic patients |
Primary outcome
PaO2/FiO2 ratio
Time frame: first three days after admission
1 secondary outcome
Length of ICU
Time frame: first month after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sodium Balance, run by Ain Shams University at 1 site in Egypt.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 ratio (time frame: first three days after admission). 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 29 Aug 2025.