Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

July 1, 2020 updated by: Ayman Anis Metry
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

317

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study included all patients admitted to ICU for sepsis, severe sepsis and septic shock.

All patients included except mentioned above exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normo-phosphatemia
238 patients included in this group. Phosphorus level >2.5 mg/dl
Diagnostic test: Phosphorus level
infusion
Other Names:
  • sodium-phosphate 10 ml vial
Hypophosphatemia
79 patients included in this group. Phosphorus level <2.5 mg/dl
Diagnostic test: Phosphorus level
infusion
Other Names:
  • sodium-phosphate 10 ml vial

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ayman Anis Metry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASUH612/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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