Mechanical Ventilation
Conditions
Keywords
Mechanical ventilation, Phosphorus, Critical illness, Ventilator weaning
Brief summary
The goal of this clinical trial is to test the impact of serum phosphorus level optimization on weaning from mechanical ventilation in adult ICU patients in Alexandria University Hospitals. The main questions it aims to answer are: * Does serum phosphorus level optimization affect the duration of mechanical ventilation? * Is serum phosphorus level optimization associated with successful weaning from mechanical ventilation? In critically ill patients, phosphorus supplementation is done using Sodium glycerophosphate pentahydrate solution.
Detailed description
Investigators will document patients' data in terms of independent variables and will randomly allocate the participants into one of the two study groups mentioned below. * Control group, defined by maintaining serum phosphorus level at ≥ 2.5 and \< 3.5 mg/dL. * Intervention group, defined by optimization of serum phosphorus P to ≥ 3.5 and ≤ 4.5 mg/dL (Average 4mg/dL). Regression and comparative statistics will be used to determine whether the optimum serum phosphorus level offers a benefit in terms of the duration of mechanical ventilation and the success of weaning from mechanical ventilation.
Interventions
DRUGSodium glycerophosphate pentahydrate solution
Glycophos is a 20 ml vial of Sodium glycerophosphate pentahydrate containing 1 mmol glycerophosphate and 2 mmol sodium per ml
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult mechanically ventilated ICU patients. * Age ≥ 18 years.
Exclusion criteria
* Age \<18 years * Hypernatremia * Permanent or prolonged mechanical ventilation * Hyperphosphatemia which might occur in the following conditions: * Chronic kidney disease and end stage renal disease * Parathyroid disorders * Cancer patients at risk of tumor lysis syndrome * Immobility * Body weight \< 50 Kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The duration of mechanical ventilation. | 4 months | Comparison of mechanical ventilation days for patients in the two study groups. |
| Weaning from mechanical ventilation. | 4 months | Association of serum phosphorus level optimization to ≥ 3.5 and ≤ 4.5 mg/dL with success of weaning from mechanical ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU stay | 4 months | Change in the ICU length of stay in the intervention group with respect to the control group |
| ICU mortality | 4 months | Change in the ICU mortality in the intervention group with respect to the control group. |
| Cost effectiveness analysis | 4 months | Cost-effectiveness analysis of serum phosphorus level optimization. |
Countries
Egypt
Outcome results
None listed