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Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

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ClinicalTrials.gov Identifier: NCT04455113
Recruitment Status : Completed
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Ayman Anis Metry, Ain Shams University

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

Condition or disease Intervention/treatment
Effect of Hypophosphatemia on Septic Patients Diagnostic Test: Phosphorus level

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.

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Study Type : Observational
Actual Enrollment : 317 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
Drug Information available for: Phosphorus

Group/Cohort Intervention/treatment
Normo-phosphatemia
238 patients included in this group. Phosphorus level >2.5 mg/dl
Diagnostic Test: Phosphorus level
infusion
Other Name: sodium-phosphate 10 ml vial

Hypophosphatemia
79 patients included in this group. Phosphorus level <2.5 mg/dl
Diagnostic Test: Phosphorus level
infusion
Other Name: sodium-phosphate 10 ml vial




Primary Outcome Measures :
  1. The 28-day ICU mortality rate (28-MR) [ Time Frame: 28 days ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455113


Locations
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Egypt
Ain Shams University hospitals
Cairo, Egypt
Sponsors and Collaborators
Ayman Anis Metry
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Responsible Party: Ayman Anis Metry, Assistant professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04455113    
Other Study ID Numbers: ASUH612/18
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypophosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases