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Levels of 'Hypophosphatemia Affect Outcome of Septic Patients in ICU

Primary Purpose

Hypophosphatemia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Glycophos (Sodium Glycerophosphate)
Antibiotics
Inotropes
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypophosphatemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with severe sepsis and/or septic shock within 24 hours of admission to ICU

Exclusion Criteria:

  • children and adulthoods younger than 18 years
  • pregnancy
  • severe hemorrhagic shock
  • maintenance on immunosuppressant therapy for any indication
  • patients who are expected to die within the first 24 hours after admission

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Active Comparator

    Arm Label

    Control group

    Study group

    Arm Description

    Management of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes.

    Management of sepsis/ septic shock in addition to management of hypophosphatemia.

    Outcomes

    Primary Outcome Measures

    Mortality (No.)
    Assessment of mortality Assessment of mortality
    Mortality (%)
    Assessment of mortality

    Secondary Outcome Measures

    Full Information

    First Posted
    August 12, 2020
    Last Updated
    August 17, 2020
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04519762
    Brief Title
    Levels of 'Hypophosphatemia Affect Outcome of Septic Patients in ICU
    Official Title
    Hupophosphatemia Levels Deleteriously Affect Outcome of Patients With Severe Sepsis/Septic Shock Admitted to ICU
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2020 (Anticipated)
    Primary Completion Date
    December 15, 2020 (Anticipated)
    Study Completion Date
    December 15, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The current study aimed to determine the incidence of hypophosphatemia (HP) among severe sepsis/septic shock patients admitted to ICU and its impact on morbidity and mortality rates of these patients, and to evaluate the impact of phosphorous supplemental therapy (PST) on such outcomes.Thus, this study will hypothesize that diagnosis and management of HP may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to ICU.
    Detailed Description
    The study will include all patients admitted to ICU with or developing severe sepsis or septic shock within 24-hr after admission to ICU. Patients will be categorized according to at-admission inorganic phosphate (Pi) level into normophosphatemia group and hypophosphatemia group (HP) (mild, moderate and severe HP). All patients will be evaluated using Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II score (APACHE II) and blood samples will be collected for ELISA estimation of serum Pi, human C-reactive protein (CRP), L-lactate, CBC picture , serum electrolytes and kidney and liver function tests. Serum Pi level will be re-estimated immediately and 24-hr after full dose administration. Outcomes will include the 28-day ICU morbidity and mortality rates and their relation to HP severity and PST administration. Patients who will fulfill the inclusion criteria will be selectively divided into two groups according to estimated level of serum Pi: Control group will include patients with serum Pi >2.5 mg/dl and Study group will include patients having serum Pi<2.5 mg/dl and will be further sub-grouped according to severity of HP into mild HP (2-2.5 mg/dl), moderate (1-1.9 mg/dl) or severe (<1 mg/dl). Central venous catheter will be inserted for all patients enrolled in the study via the jugular or subclavian vein. Then, baseline hemodynamic parameters and central venous pressure (CVP) will be estimated and will be continuously monitored. Arterial blood samples will be obtained anaerobically and collected in heparinized tubes for estimation of arterial blood gas and pH. Sepsis management: Patients were managed according to guidelines of Surviving Sepsis Campaign; briefly: Fluid therapy Vasoactive drug therapy Intropics Antibiotic therapy HP management regimen follows: Calculation of supplementation dose according to the equation: phosphate dose (in mmol) = 0.5 x body weight x (1.25 - [serum Pi]). Preparation that will be used: Glycophos®, Fresenius Kabi Egypt (organic phosphate solution 1mmol/ml). Vial 20 ml (1ml contains 1mmol of phosphate and 2mmol of sodium). Dilution: will be diluted prior to parenteral administration. 20 ml of sodium-glycerophosphate diluted in 30 cc of dextrose 5% administered by syringe pump (50 mL). The total calculated dose will be divided into three doses every 8 hours.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypophosphatemia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    Management of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes.
    Arm Title
    Study group
    Arm Type
    Active Comparator
    Arm Description
    Management of sepsis/ septic shock in addition to management of hypophosphatemia.
    Intervention Type
    Drug
    Intervention Name(s)
    Glycophos (Sodium Glycerophosphate)
    Other Intervention Name(s)
    Saline
    Intervention Description
    Management of hypophosphatemia via Glycophos Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
    Intervention Type
    Drug
    Intervention Name(s)
    Antibiotics
    Other Intervention Name(s)
    saline
    Intervention Description
    Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
    Intervention Type
    Drug
    Intervention Name(s)
    Inotropes
    Other Intervention Name(s)
    saline
    Intervention Description
    Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
    Primary Outcome Measure Information:
    Title
    Mortality (No.)
    Description
    Assessment of mortality Assessment of mortality
    Time Frame
    15 September 2020 - 15 December 2020 (3 months)
    Title
    Mortality (%)
    Description
    Assessment of mortality
    Time Frame
    15 September 2020 - 15 December 2020 (3 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with severe sepsis and/or septic shock within 24 hours of admission to ICU Exclusion Criteria: children and adulthoods younger than 18 years pregnancy severe hemorrhagic shock maintenance on immunosuppressant therapy for any indication patients who are expected to die within the first 24 hours after admission
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Noha Hussien, Dr.
    Phone
    +201222830981
    Email
    nohasayedhussien@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sherif Anis, Dr.
    Phone
    +2001222421674
    Email
    sherifganis@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Kamal, Dr.
    Organizational Affiliation
    Ain Shams University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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