Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

Study Overview
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Brief Summary
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Patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of developing morbidities other than that underlying sepsis and more vulnerable to higher mortality rate. Thus, the current study hypothesized that diagnosis and management of hypophosphatemia may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to ICU

Detailed Description
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The current study was started since June 2018 till Jan 2020 after approval of the study protocol by the Local Ethical Committee. The study intended to include all patients admitted to ICU with or developed severe sepsis or septic shock within 24-hr after admission to ICU. All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data. Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores. Exclusion criteria included maintenance on immunodepressent therapy for any indication, severe hemorrhagic shock, pregnancy and refusal of nearest relative to sign the written concept for study participation. Children and adulthoods younger than 18 years and patients who were expected to die were also excluded from the study.

Official Title
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Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

Conditions
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Effect of Hypophosphatemia on Septic Patients

Intervention / Treatment
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* Diagnostic Test: Phosphorus level


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data. Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores. Exclusion Criteria: Maintenance on immunodepressent therapy. Severe hemorrhagic shock. Pregnancy Refusal of nearest relative to sign the written concept for study participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normo-phosphatemia<br>238 patients included in this group. Phosphorus level >2.5 mg/dl | Diagnostic Test: Phosphorus level<br>* infusion<br>* Other names: sodium-phosphate 10 ml vial;|
| Hypophosphatemia<br>79 patients included in this group. Phosphorus level <2.5 mg/dl | Diagnostic Test: Phosphorus level<br>* infusion<br>* Other names: sodium-phosphate 10 ml vial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 28-day ICU mortality rate (28-MR) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of additional morbidities. |  | 30 days | 
| The correlation between 28-MR and incidence of additional morbidities and severity of HP. |  | 28 days |