ClinicalTrials.gg
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verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.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
01

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

In context

Hypophosphatemia

53 studies on the registry are indexed under Hypophosphatemia; 16 are open to participants now.

This study's planned enrollment of 100 is above the median of 46 across 26 interventional studies indexed under Hypophosphatemia.

Browse Hypophosphatemia studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 therapy for any indication
  • patients who are expected to die within the first 24 hours after admission
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

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

  • 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

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

    Also known as: saline

06

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)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2020; primary completion for Dec 2020, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2020
First posted
Aug 20, 2020
StartEst.
Sep 15, 2020
Primary completionEst.
Dec 15, 2020
CompletionEst.
Dec 15, 2020
Last update
Aug 20, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04519762
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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Studies of the drug tested here: Alpha-glycerophosphoric acid

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