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Status unknownNCT04519762Updated Aug 20, 2020

Levels of 'Hypophosphatemia Affect Outcome of Septic Patients in ICU

A Phase 4 interventional study of Glycophos (Sodium Glycerophosphate) and Antibiotics in Hypophosphatemia, sponsored by Ain Shams University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by Ain Shams University · Phase 4, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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:

  1. Fluid therapy
  2. Vasoactive drug therapy
  3. Intropics
  4. Antibiotic therapy

HP management regimen follows:

  1. Calculation of supplementation dose according to the equation: phosphate dose (in mmol) = 0.5 x body weight x (1.25 - [serum Pi]).
  2. 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).
  3. 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).
  4. The total calculated dose will be divided into three doses every 8 hours.
02

Conditions studied

  • Hypophosphatemia

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03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (estimated)

Study arms

  • Sham comparator
    Control group

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

    Drug: Antibiotics · Drug: Inotropes

  • Active comparator
    Study group

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

    Drug: Glycophos (Sodium Glycerophosphate) · Drug: Antibiotics · Drug: Inotropes

Interventions

  • DrugGlycophos (Sodium Glycerophosphate)

    Management of hypophosphatemia via Glycophos Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.

    Also known as: Saline

  • DrugAntibiotics

    Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.

    Also known as: saline

  • DrugInotropes

    Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.

    Also known as: saline

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What researchers measure

Primary outcomes

  1. Mortality (No.)

    Assessment of mortality Assessment of mortality

    Time frame: 15 September 2020 - 15 December 2020 (3 months)

  2. Mortality (%)

    Assessment of mortality

    Time frame: 15 September 2020 - 15 December 2020 (3 months)

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04519762
Lead sponsor
Ain Shams University
Responsible party
Noha Sayed Hussien (Clinical Professor, Ain Shams University) — Principal investigator
First posted
Aug 20, 2020
Start date
Sep 15, 2020 (estimated)
Primary completion
Dec 15, 2020 (estimated)
Completion
Dec 15, 2020 (estimated)
Last update
Aug 20, 2020

Study contacts

Noha Hussien, Dr.
Contact
nohasayedhussien@gmail.com
+201222830981
Sherif Anis, Dr.
Contact
sherifganis@hotmail.com
+2001222421674
Ahmed Kamal, Dr.
principal investigator · Ain Shams University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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