Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

Effect of Hypophosphatemia on Septic Patients Clinical Trial

Official title:

Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455113
• Other study ID #: ASUH612/18
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Effect of Hypophosphatemia on Septic Patients
• Hypophosphatemia

Intervention

Diagnostic Test:
• Phosphorus level
infusion

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ayman Anis Metry

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 28-day ICU mortality rate (28-MR)		28 days
Secondary	The incidence of additional morbidities.		30 days
Secondary	The correlation between 28-MR and incidence of additional morbidities and severity of HP.		28 days