Electrolyte ImbalanceNCT05052463
Electrolyte Imbalance Analysis at Intensive Care Unit Admission : Retrospective Study
An observational study of Electrolyte Imbalance, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The type and severity of electrolyte imbalance in patients admitted to the intensive care unit were analyzed.It was evaluated whether these results had an effect on mortality, length of hospital stay, APACHE II scores and ventilator days Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electrolyte Imbalance
- What is being tested?
- electrolyte imbalance analysis
- How many people
- 824 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2019to 15 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ıcu patients
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Kecioren Training and Research Hospital
Ankara, Çankaya
About this study
Official title: Electrolyte Imbalance Analysis at Icu Admission : Retrospective Study
The type and severity of electrolyte imbalance in patients admitted to the intensive care unit were analyzed.It was evaluated whether these results had an effect on mortality, length of hospital stay, APACHE II scores and ventilator days
- Conditions
- Electrolyte Imbalance
- Being tested
- electrolyte imbalance analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrolyte imbalance analysisOther
ın this retrospective study we aimed to evaluate the relationship between the ıcu prognosis and the electrolyte imbalance
| Study group | Role | What they receive |
|---|---|---|
| sodium (hypo-hyper-normonatremia) | Not described Receives: Other: electrolyte imbalance analysis | |
| potassium (hypo-hyper-normokalemia) | Not described Receives: Other: electrolyte imbalance analysis | |
| calcium (hyper-hypo-normocalcemia) | Not described Receives: Other: electrolyte imbalance analysis | |
| magnesium (hyper-hypo-normocalcemia) | Not described Receives: Other: electrolyte imbalance analysis | |
| phosphor (hypo-hyper-normophosphatemia) | Not described Receives: Other: electrolyte imbalance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The analysis the electrolyte imbalance in ICU and the relationship between the icu prognosis.
Natremia (Hypo: <136 mmol/L, Normo: 136-145 mmol/L, Hyper: >145 mmol/L) Kalemia (Hypo: <3.5 mmol/L, Normo: 3.5-5.5 mmol/L, Hyper: >5.5 mmol/L) Calcemia (Hypo: <8.8 mg/dL, Normo: 8.8-10.6 mg/dL, Hyper: >10.6 mg/dL) Magnesemia (Hypo: <1.9 mg/dL, Normo: 1.9-2.5 mg/dL, Hyper: >2.5 mg/dL) Phosphatemia (Hypo: <2.5 mg/dL, Normo: 2.5-4.5 mg/dL, Hyper: >4.5 mg/dL)
The number of patients in all types of electrolyte imbalance will be determined. The effect of the type of electrolyte imbalance on mortality, APACHE-II score and length of invasive ventilation and hospital stay will be evaluated.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start10 Dec 2019
- Primary completion5 Apr 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrolyte ImbalanceStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 824 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kecioren Education and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA OZAYAR, Kecioren Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052463
- Sponsor's protocol ID
- erbil elektrolit
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrolyte Imbalance Analysis at Icu Admission : Retrospective Study
- ClinicalTrials.gov ID
- NCT05052463
- Acronym / sponsor ID
- erbil elektrolit
- Conditions
- Electrolyte Imbalance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 22 Sep 2021 (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 type and severity of electrolyte imbalance in patients admitted to the intensive care unit were analyzed.It was evaluated whether these results had an effect on mortality, length of hospital stay, APACHE II scores and ventilator days
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| sodium (hypo-hyper-normonatremia) | – | Other: electrolyte imbalance analysis |
| potassium (hypo-hyper-normokalemia) | – | Other: electrolyte imbalance analysis |
| calcium (hyper-hypo-normocalcemia) | – | Other: electrolyte imbalance analysis |
| magnesium (hyper-hypo-normocalcemia) | – | Other: electrolyte imbalance analysis |
| phosphor (hypo-hyper-normophosphatemia) | – | Other: electrolyte imbalance analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ıcu patients
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| electrolyte imbalance analysisın this retrospective study we aimed to evaluate the relationship between the ıcu prognosis and the electrolyte imbalance | Other | calcium (hyper-hypo-normocalcemia), magnesium (hyper-hypo-normocalcemia), phosphor (hypo-hyper-normophosphatemia), potassium (hypo-hyper-normokalemia), sodium (hypo-hyper-normonatremia) |
Primary outcome
The analysis the electrolyte imbalance in ICU and the relationship between the icu prognosis.
Time frame: 2 years
Natremia (Hypo: <136 mmol/L, Normo: 136-145 mmol/L, Hyper: >145 mmol/L) Kalemia (Hypo: <3.5 mmol/L, Normo: 3.5-5.5 mmol/L, Hyper: >5.5 mmol/L) Calcemia (Hypo: <8.8 mg/dL, Normo: 8.8-10.6 mg/dL, Hyper: >10.6 mg/dL) Magnesemia (Hypo: <1.9 mg/dL, Normo: 1.9-2.5 mg/dL, Hyper: >2.5 mg/dL) Phosphatemia (Hypo: <2.5 mg/dL, Normo: 2.5-4.5 mg/dL, Hyper: >4.5 mg/dL) The number of patients in all types of electrolyte imbalance will be determined. The effect of the type of electrolyte imbalance on mortality, APACHE-II score and length of invasive ventilation and hospital stay will be evaluated.
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 28 Sep 2021.
- Individual participant dataSharing planned: No
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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.
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 Electrolyte Imbalance, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
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 0 inclusion and 1 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 28 Sep 2021. 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 Turkey (Türkiye). 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 analysis the electrolyte imbalance in ICU and the relationship between the icu prognosis. (time frame: 2 years). 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 28 Sep 2021.