Effect of Hypophosphatemia on Septic PatientsNCT04455113
Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU
An observational study of Effect of Hypophosphatemia on Septic Patients, run by Ayman Anis Metry at 1 site in Egypt.
Trial summary
Patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of developing morbidities other than that underlying sepsis and more vulnerable to higher mortality rate. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Effect of Hypophosphatemia on Septic Patients
- What is being tested?
- Phosphorus level
- Type of treatment
- Injection or infusion
- How many people
- 317 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 1 Jun 2020
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included all patients admitted to ICU for sepsis, severe sepsis and septic shock. All patients included except mentioned above exclusion criteria.
Who may be able to join
- All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data.
- Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores.
Who cannot join
- Maintenance on immunodepressent therapy.
- Severe hemorrhagic shock.
- Pregnancy
- Refusal of nearest relative to sign the written concept for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of developing morbidities other than that underlying sepsis and more vulnerable to higher mortality rate. Thus, the current study hypothesized that diagnosis and management of hypophosphatemia may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to ICU
Read the detailed description
The current study was started since June 2018 till Jan 2020 after approval of the study protocol by the Local Ethical Committee. The study intended to include all patients admitted to ICU with or developed severe sepsis or septic shock within 24-hr after admission to ICU.
All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data. Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores. Exclusion criteria included maintenance on immunodepressent therapy for any indication, severe hemorrhagic shock, pregnancy and refusal of nearest relative to sign the written concept for study participation. Children and adulthoods younger than 18 years and patients who were expected to die were also excluded from the study.
- Being tested
- Phosphorus level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phosphorus levelDiagnostic test
Also called sodium-phosphate 10 ml vial
infusion
| Study group | Role | What they receive |
|---|---|---|
| Normo-phosphatemia | 238 patients included in this group. Phosphorus level >2.5 mg/dl Receives: Diagnostic Test: Phosphorus level | |
| Hypophosphatemia | 79 patients included in this group. Phosphorus level <2.5 mg/dl Receives: Diagnostic Test: Phosphorus level |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 28-day ICU mortality rate (28-MR)
Measured: 28 days
Secondary outcomes (2)
The incidence of additional morbidities.
Measured: 30 days
The correlation between 28-MR and incidence of additional morbidities and severity of HP.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jun 2018
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Hypophosphatemia on Septic PatientsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayman Anis Metry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayman Anis Metry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455113
- Sponsor's protocol ID
- ASUH612/18
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2020
- Last updated
- 2 Jul 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 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU
- ClinicalTrials.gov ID
- NCT04455113
- Acronym / sponsor ID
- ASUH612/18
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Ayman Anis MetryUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 2 Jul 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.
Patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of developing morbidities other than that underlying sepsis and more vulnerable to higher mortality rate. Thus, the current study hypothesized that diagnosis and management of hypophosphatemia may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to ICU
Detailed description
The current study was started since June 2018 till Jan 2020 after approval of the study protocol by the Local Ethical Committee. The study intended to include all patients admitted to ICU with or developed severe sepsis or septic shock within 24-hr after admission to ICU.
All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data. Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores. Exclusion criteria included maintenance on immunodepressent therapy for any indication, severe hemorrhagic shock, pregnancy and refusal of nearest relative to sign the written concept for study participation. Children and adulthoods younger than 18 years and patients who were expected to die were also excluded from the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normo-phosphatemia | – | Diagnostic Test: Phosphorus level238 patients included in this group. Phosphorus level >2.5 mg/dl |
| Hypophosphatemia | – | Diagnostic Test: Phosphorus level79 patients included in this group. Phosphorus level <2.5 mg/dl |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included all patients admitted to ICU for sepsis, severe sepsis and septic shock. All patients included except mentioned above exclusion criteria.
Key inclusion criteria (2 listed)
- All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data.
- Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores.
Key exclusion criteria (4 listed)
- Maintenance on immunodepressent therapy.
- Severe hemorrhagic shock.
- Pregnancy
- Refusal of nearest relative to sign the written concept for study participation.
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 |
|---|---|---|
| Phosphorus levelAlso: sodium-phosphate 10 ml vialinfusion | Diagnostic test | Hypophosphatemia, Normo-phosphatemia |
Primary outcome
The 28-day ICU mortality rate (28-MR)
Time frame: 28 days
2 secondary outcomes
The incidence of additional morbidities.
Time frame: 30 days
The correlation between 28-MR and incidence of additional morbidities and severity of HP.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effect of Hypophosphatemia on Septic Patients, run by Ayman Anis Metry at 1 site in Egypt.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 28-day ICU mortality rate (28-MR) (time frame: 28 days). 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 2 Jul 2020.