Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

NCT ID: NCT04455113

Last Updated: 2020-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

317 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-06-01

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.

Conditions

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Effect of Hypophosphatemia on Septic Patients

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Normo-phosphatemia

238 patients included in this group. Phosphorus level \>2.5 mg/dl

Phosphorus level

Intervention Type DIAGNOSTIC_TEST

infusion

Hypophosphatemia

79 patients included in this group. Phosphorus level \<2.5 mg/dl

Phosphorus level

Intervention Type DIAGNOSTIC_TEST

infusion

Interventions

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Phosphorus level

infusion

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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sodium-phosphate 10 ml vial

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ayman Anis Metry

OTHER

Sponsor Role lead

Responsible Party

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Ayman Anis Metry

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ain Shams University hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ASUH612/18

Identifier Type: -

Identifier Source: org_study_id

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