Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

Completed

• Conditions: Effect of Hypophosphatemia on Septic Patients
• Interventions: Diagnostic Test: Phosphorus level

• Registration Number: NCT04455113
• Lead Sponsor: Ayman Anis Metry

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Study First Submitted: 2020-06-29
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-01
• Last Update Submitted: 2020-07-01
• Study First Posted: 2020-07-02
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypophosphatemia	Phosphorus level	79 patients included in this group. Phosphorus level \<2.5 mg/dl
Normo-phosphatemia	Phosphorus level	238 patients included in this group. Phosphorus level \>2.5 mg/dl

Primary Outcome Measures

Name	Time	Method
The 28-day ICU mortality rate (28-MR)	28 days

Secondary Outcome Measures

Name	Time	Method
The correlation between 28-MR and incidence of additional morbidities and severity of HP.	28 days
The incidence of additional morbidities.	30 days

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt