BurnsNCT06561282
Predictive Role of Glucose/Potassium Ratio on Mortality in Major Burns.
An observational study of Burns and Burn Injury, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to investigate the role of the glucose-potassium ratio in predicting mortality in patients with major burn trauma. The main question it aims to answer is: Can the glucose-potassium ratio predict mortality in major burn patients? The glucose-to-potassium ratios of major burn… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns, Burn Injury, Inhalation Injury
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Jul 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consisted of patients of all age groups who were admitted to the burn center between May 2022 and May 2024 with 2nd degree and deeper burns of 40% and above total burn surface area, 3rd and 4th degree burns of 20% and above total burn surface area, and inhalation burns. Patients with missing data, patients with burn trauma of more than 24 hours since the onset of burn trauma, 1st degree burns, patients with diabetes mellitus or renal failure, and patients using potassium-regulating drugs were excluded from the study.
Who may be able to join
- All burns >40% of total body surface area (2nd degree or deeper)
- Burns with inhalation injury
- Burns >20% of total body surface area 3nd degree or deeper
Who cannot join
- First degree burns
- Patients have more than 24 hours since the onset of burn trauma
- Patients with diabetes mellitus
- Patients with chronic renal failure
- Patients taking potassium-modifying medication
- Patients with missing data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: The Predictive Role of Glucose/Potassium Ratio for Mortality in Patients With Major Burn Trauma
The aim of this observational study is to investigate the role of the glucose-potassium ratio in predicting mortality in patients with major burn trauma.
The main question it aims to answer is: Can the glucose-potassium ratio predict mortality in major burn patients? The glucose-to-potassium ratios of major burn patients at the time of initial hospitalization will be determined, and their relationship with mortality will be analyzed.
Read the detailed description
Major burns, especially electrical burns, facial burns, inhalation burns, burns with large burn surface areas, and deep burns, have a high mortality risk. Early detection of this risk may be critical to reducing mortality rates. For this reason, trauma centers are working on rapid and effective prognostic markers. In trauma and stress situations, glucose levels rise while potassium levels fall due to increased catecholamines. The literature reports that hyperglycemia, also known as the glucose-potassium ratio, can rapidly and effectively predict morbidity and mortality in patients suffering from subarachnoid hemorrhage, pulmonary embolism, traumatic brain injury, or blunt abdominal trauma. Many publications show that increased glucose is associated with mortality and morbidity in critical illnesses and trauma. The isolated glucose-potassium ratio has a higher predictive ability for mortality and morbidity compared to glucose and potassium levels. In this study, investigators aimed to examine the prognostic value of the glucose-to-potassium ratio in participants with major burn trauma.
- Conditions
- Burns, Burn Injury, Inhalation Injury
- Medical subject headings
- Burns
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose-to-potassium ratio
The glucose-to-potassium ratio is calculated by dividing the participants' glucose values when they first apply to the hospital by their potassium values.
Measured: 2 days
Secondary outcomes (4)
Female/Male ratio
It is calculated by dividing the number of females by the number of males in the study population.
Measured: 2 days
Mean percent of total body surface area burned
It is calculated by adding the total burn surface area percentage values of all patients and dividing by the number of participants.
Measured: 2 days
Burn infection rate
The number of patients developing burn infection is calculated by dividing by the number of all participants.
Measured: 2 days
Mortality rate
The mortality rate is calculated by dividing the number of patients who developed mortality by the number of all participants.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 May 2022
- Primary completion1 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alpaslan Şahin, Konya Meram State Hospital
- Investigators
- Alpaslan Sahin, Assoc. Prof., Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561282
- Sponsor's protocol ID
- Konya Burn Center
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Role of Glucose/Potassium Ratio for Mortality in Patients With Major Burn Trauma
- ClinicalTrials.gov ID
- NCT06561282
- Acronym / sponsor ID
- Konya Burn Center
- Conditions
- Burns, Burn Injury, Inhalation Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 20 Aug 2024 (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 aim of this observational study is to investigate the role of the glucose-potassium ratio in predicting mortality in patients with major burn trauma.
The main question it aims to answer is: Can the glucose-potassium ratio predict mortality in major burn patients? The glucose-to-potassium ratios of major burn patients at the time of initial hospitalization will be determined, and their relationship with mortality will be analyzed.
Detailed description
Major burns, especially electrical burns, facial burns, inhalation burns, burns with large burn surface areas, and deep burns, have a high mortality risk. Early detection of this risk may be critical to reducing mortality rates. For this reason, trauma centers are working on rapid and effective prognostic markers. In trauma and stress situations, glucose levels rise while potassium levels fall due to increased catecholamines. The literature reports that hyperglycemia, also known as the glucose-potassium ratio, can rapidly and effectively predict morbidity and mortality in patients suffering from subarachnoid hemorrhage, pulmonary embolism, traumatic brain injury, or blunt abdominal trauma. Many publications show that increased glucose is associated with mortality and morbidity in critical illnesses and trauma. The isolated glucose-potassium ratio has a higher predictive ability for mortality and morbidity compared to glucose and potassium levels. In this study, investigators aimed to examine the prognostic value of the glucose-to-potassium ratio in participants with major burn trauma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consisted of patients of all age groups who were admitted to the burn center between May 2022 and May 2024 with 2nd degree and deeper burns of 40% and above total burn surface area, 3rd and 4th degree burns of 20% and above total burn surface area, and inhalation burns. Patients with missing data, patients with burn trauma of more than 24 hours since the onset of burn trauma, 1st degree burns, patients with diabetes mellitus or renal failure, and patients using potassium-regulating drugs were excluded from the study.
Key inclusion criteria (3 listed)
- All burns >40% of total body surface area (2nd degree or deeper)
- Burns with inhalation injury
- Burns >20% of total body surface area 3nd degree or deeper
Key exclusion criteria (6 listed)
- First degree burns
- Patients have more than 24 hours since the onset of burn trauma
- Patients with diabetes mellitus
- Patients with chronic renal failure
- Patients taking potassium-modifying medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glucose-to-potassium ratio
Time frame: 2 days
The glucose-to-potassium ratio is calculated by dividing the participants' glucose values when they first apply to the hospital by their potassium values.
4 secondary outcomes
Female/Male ratio
Time frame: 2 days
Mean percent of total body surface area burned
Time frame: 2 days
Burn infection rate
Time frame: 2 days
Mortality rate
Time frame: 2 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 21 Aug 2024.
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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.
Alpaslan Sahin, Assoc. Prof. principal investigator
Principal Investigator
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 Burns and Burn Injury, run by Konya Meram State 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 3 inclusion and 6 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 21 Aug 2024. 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?
Glucose-to-potassium ratio (time frame: 2 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 21 Aug 2024.