Evaluating sodium balance's impact on respiratory function in critically ill septic patients

Sodium Balance Rather Than Fluid Balance As a Predictor of Respiratory Dysfunction in Critically Ill Septic Patients on Mechanical Ventilation; a Prospective Observational Study

This study is trying to see if the amount of sodium in the body affects how well critically ill septic patients on breathing machines are able to breathe.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 13 Years to 70 Years
• Sex: All
• Sponsor: Ain Shams University (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT06771869 on ClinicalTrials.gov

What this trial studies

This observational cohort study investigates the relationship between sodium balance and respiratory function in critically ill septic patients on mechanical ventilation for over 48 hours. It includes patients aged 13 to 70 with specific APACHE II and SOFA scores, and collects data on sodium intake, fluid balance, and respiratory parameters over three days. The study aims to understand how positive sodium balance affects the PaO2/FiO2 ratio and the duration of mechanical ventilation.

Who should consider this trial

Good fit: Ideal candidates are critically ill septic patients aged 13 to 70 who are mechanically ventilated and have specific APACHE II and SOFA scores.

Not a fit: Patients outside the age range of 13 to 70, those with traumatic brain injury, or those with certain acute conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of sodium levels in critically ill septic patients, potentially enhancing respiratory function and outcomes.

How similar studies have performed: While there is limited data on this specific approach, similar studies have explored sodium balance in critically ill patients, indicating potential relevance.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. Temperature \>38oC or \<36oC
  2. Heart rate \>90 beats/min
  3. Respiratory rate \>20 breaths/min or PaCO2 \<32mmHg.
  4. 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

Exclusion Criteria:

* 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).

Where this trial is running

Cairo

• Ain Shams University — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Rania M Hussien, MD

Conditions Sodium Balance