HypophosphatemiaPhase 4NCT04519762
Levels of 'Hypophosphatemia Affect Outcome of Septic Patients in ICU
A Phase 4 study testing Glycophos (Sodium Glycerophosphate), Antibiotics and Inotropes in people with Hypophosphatemia, run by Ain Shams University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypophosphatemia
- What is being tested?
- Glycophos (Sodium Glycerophosphate), Antibiotics and Inotropes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2020to 15 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with severe sepsis and/or septic shock within 24 hours of admission to ICU
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hupophosphatemia Levels Deleteriously Affect Outcome of Patients With Severe Sepsis/Septic Shock Admitted to ICU
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:
- 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.
- Conditions
- Hypophosphatemia
- Being tested
- Glycophos (Sodium Glycerophosphate), Antibiotics, Inotropes
- Medical subject headings
- Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycophos (Sodium Glycerophosphate)Drug
Also called Saline
Management of hypophosphatemia via Glycophos Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
AntibioticsDrug
Also called saline
Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
InotropesDrug
Also called saline
Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Management of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes. Receives: Drug: Antibiotics; Drug: Inotropes |
| Study group | Active comparator | Management of sepsis/ septic shock in addition to management of hypophosphatemia. Receives: Drug: Glycophos (Sodium Glycerophosphate); Drug: Antibiotics; Drug: Inotropes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality (No.)
Assessment of mortality Assessment of mortality
Measured: 15 September 2020 - 15 December 2020 (3 months)
Mortality (%)
Assessment of mortality
Measured: 15 September 2020 - 15 December 2020 (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start15 Sep 2020 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypophosphatemiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Sayed Hussien, Ain Shams University
- Investigators
- Ahmed Kamal, Dr., Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519762
- Sponsor's protocol ID
- R38/2020
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hupophosphatemia Levels Deleteriously Affect Outcome of Patients With Severe Sepsis/Septic Shock Admitted to ICU
- ClinicalTrials.gov ID
- NCT04519762
- Acronym / sponsor ID
- R38/2020
- Conditions
- Hypophosphatemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Drug: Antibiotics, Drug: InotropesManagement of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes. |
| Study group | Active comparator | Drug: Glycophos (Sodium Glycerophosphate), Drug: Antibiotics, Drug: InotropesManagement of sepsis/ septic shock in addition to management of hypophosphatemia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with severe sepsis and/or septic shock within 24 hours of admission to ICU
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycophos (Sodium Glycerophosphate)Also: SalineManagement of hypophosphatemia via Glycophos Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics. | Drug | Study group |
| AntibioticsAlso: salineManagement of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics. | Drug | Control group, Study group |
| InotropesAlso: salineManagement of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics. | Drug | Control group, Study group |
Primary outcome
Mortality (No.)
Time frame: 15 September 2020 - 15 December 2020 (3 months)
Assessment of mortality Assessment of mortality
Mortality (%)
Time frame: 15 September 2020 - 15 December 2020 (3 months)
Assessment of mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Individual participant dataSharing planned: No
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Study of the Impact of Phosphate Supplementation on FGF23 Concentrations in Patients With Hypophosphatemia
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Not yet recruitingObservational study
Respiratory Quotient and Phosphate Changes During Early Critical Illness
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Kamal, Dr. principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glycophos (Sodium Glycerophosphate), Antibiotics and Inotropes in people with Hypophosphatemia, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha Hussien, Dr. (+201222830981, nohasayedhussien@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (No.) (time frame: 15 September 2020 - 15 December 2020 (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.