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Completed

NCT Number: NCT04455113

Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

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

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Key information

Conditions

Effect of Hypophosphatemia on Septic Patients

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University hospitals

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phosphorus level

Diagnostic Test

infusion

Other names: sodium-phosphate 10 ml vial

Primary outcomes

  1. The 28-day ICU mortality rate (28-MR)

    Time frame: 28 days

Secondary outcomes

  1. The incidence of additional morbidities.

    Time frame: 30 days

  2. The correlation between 28-MR and incidence of additional morbidities and severity of HP.

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Ayman Anis Metry

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.