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
About this trial
This is an interventional diagnostic trial for Hypophosphatemia
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
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
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
Learn more about this trial
Levels of 'Hypophosphatemia Affect Outcome of Septic Patients in ICU
We'll reach out to this number within 24 hrs