Brain Injury Traumatic SevereNCT07809880
Electrolyte Imbalance in Surgical and Non-Surgical Geriatric Brain Injury Patients
An observational study of Brain Injury Traumatic Severe and Serum Concentrations, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Investigators invite you to the research titled "Evaluation of Serum Electrolyte Imbalance in Geriatric Patients Undergoing Brain Surgery: A Prospective Randomized Observational Study" conducted by Specialist Nurse Tülin KURT ALKAN. Read more about this study
- Who is it for?
- Ages 65 to 92 years
- Conditions the study is for
- Brain Injury Traumatic Severe, Serum Concentrations, Nursing
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2024to 25 Oct 2024
- How long will I take part?
- 3 Months
- 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 65 to 92 years
- All sexes
- No healthy volunteers
- Older adult
Study population: The study group included geriatric patients: with and without surgery. G*Power software (version 3.1.9.7) was used for power analysis and 60 patients were included in the study. To ensure the relevance of the data, the study included patients within the first 24 hours after trauma and the first 24 hours of hospitalization. Neurological patients with or without neurosurgery, aged 65 years and older, who volunteered to participate were included in the study. Patients with chronic renal failure and heart failure using diuretics were not included in the study.
Who may be able to join
- To ensure the relevance of the data, the study included patients within the first 24 hours after trauma and the first 24 hours of hospitalization. Neurological patients with or without neurosurgery, aged 65 years and older, who volunteered to participate were included in the study.
Who cannot join
- Patients with chronic renal failure and heart failure using diuretics were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Atatürk State Hospital
Zonguldak, Center, 67030
About this study
Investigators invite you to the research titled "Evaluation of Serum Electrolyte Imbalance in Geriatric Patients Undergoing Brain Surgery: A Prospective Randomized Observational Study" conducted by Specialist Nurse Tülin KURT ALKAN. Before participant decide whether or not to participate in this research, you need to know why and how the research will be conducted. For this reason, it is of great importance to read and understand this form. Take the time to read the information below carefully. If participant want, discuss this information with participant' family and/or relatives. If there are things that participant do not understand and are not clear to participant, or if participant want more information, please ask investigators. For the purpose of the research, questions such as the patient's age, gender, chronic diseases, mechanism of injury, surgical procedure will be asked. Other data include Glaskow Coma Scale score, ASA class, cardiopulmonary resuscitation history, patient's day of stay in intensive care, number of intubated patient days, blood sugar, alanine aminotransferase, aspartate aminotransferase, urea, creatinine, serum sodium, serum potassium, serum calcium, serum chloride, serum magnesium, serum phosphorus, albumin value, as well as from participant's file/systemic data such as patient's follow-up it will be taken. According to the course of the interview, it will take about 5 minutes. With the information to be obtained in line with the interviews to be held with participant, "Evaluation of Serum Electrolyte Imbalances in Geriatric Patients Undergoing Brain Surgery: A Prospective Randomized Observational Study" will be attempted. Participation in the research is completely voluntary. If participants want to at any time while the research is ongoing, participants can leave the research provided that participants inform the responsible researcher. Participants answering the questionnaire will be interpreted as giving your consent to participate in the research. The information received from participant during the research will be kept by the researcher and the collected data will be used only for scientific purposes.
Read the detailed description
It is a well-established that patients suffering from head trauma experience at least one electrolyte disturbance. However, it appears that intensive care nurses, who are of paramount importance in the care of these critically ill patients whose homeostasis is disrupted, do not possess the necessary knowledge and skills. The study purpose is to compare the serum electrolyte imbalances of surgical and non-surgical geriatric patients with brain injury and to draw attention to the importance of nursing care. This is a single center, a prospective observational study.
- Keywords
- Nursing, Geriatric patients, Serum concentrations, Brain injury traumatic severe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgery Group | 30 neurosurgical patients | |
| Non-Surgery Group | 30 neurological patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The researcher's data form checklist
Data Form: The researcher's data form consisted of the sociodemographic characteristics of the participants (age, gender, chronic diseases, mechanism of injury) and clinical characteristics (surgical procedure, Glasgow Coma Scale score, ASA class, history of cardiopulmonary resuscitation, number of intubation days) of patients. Also, serum electrolyte values were monitored (blood glucose, alanine aminotransferase, aspartate aminotransferase, urea, creatinine, serum sodium, potassium, calcium, chloride, magnesium, serum phosphorus, and albumin).
The patients and their relatives were interviewed after ethical approval and the necessary permissions from the institution where the study was conducted. The purpose and scope of the study were explained, and they were invited to participate. Their written consent was obtained. Once the patients were hospitalized in the neurology intensive care unit, the Personal Information Form was completed and recorded over five days.
Measured: August and October 2024
Secondary outcomes (1)
Glasgow Coma Scale (GCS)
Glasgow Coma Scale (GCS): Teasdale and Jennett created it in 1974. This scale is used to evaluate the patient's level of consciousness and translate it into numerical data. This scale determines the level of consciousness by assessing the patient's best eye-opening, verbal, and motor responses. The scale allows for a minimum of 3 and 15 points. A score of between 13 and 15 points indicates full alertness and good orientation. A score of 9 and 12 points means a problem in alertness and orientation, with decreased consciousness. A score of 8 points or below indicates a coma.
After the patients were admitted to the neurology intensive care unit, their Glasgow Coma Scale scores were recorded for five days.
Measured: August-October 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start25 Aug 2024
- Primary completion25 Sep 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury Traumatic SevereStudies 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
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülin KURT ALKAN, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809880
- Sponsor's protocol ID
- 2024-SBB-0614
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age Glasgow coma scale ASA class Number of intubated days Gender Mechanism of injury Surgical procedure Resuscitation Chronically ill Electrolyte values
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrolyte Imbalance in Surgical and Non-Surgical Geriatric Brain Injury Patients
- ClinicalTrials.gov ID
- NCT07809880
- Acronym / sponsor ID
- 2024-SBB-0614
- Keywords
- Nursing, Geriatric patients, Serum concentrations, Brain injury traumatic severe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 9 Sep 2026 (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.
Investigators invite you to the research titled "Evaluation of Serum Electrolyte Imbalance in Geriatric Patients Undergoing Brain Surgery: A Prospective Randomized Observational Study" conducted by Specialist Nurse Tülin KURT ALKAN. Before participant decide whether or not to participate in this research, you need to know why and how the research will be conducted. For this reason, it is of great importance to read and understand this form. Take the time to read the information below carefully. If participant want, discuss this information with participant' family and/or relatives. If there are things that participant do not understand and are not clear to participant, or if participant want more information, please ask investigators. For the purpose of the research, questions such as the patient's age, gender, chronic diseases, mechanism of injury, surgical procedure will be asked. Other data include Glaskow Coma Scale score, ASA class, cardiopulmonary resuscitation history, patient's day of stay in intensive care, number of intubated patient days, blood sugar, alanine aminotransferase, aspartate aminotransferase, urea, creatinine, serum sodium, serum potassium, serum calcium, serum chloride, serum magnesium, serum phosphorus, albumin value, as well as from participant's file/systemic data such as patient's follow-up it will be taken. According to the course of the interview, it will take about 5 minutes. With the information to be obtained in line with the interviews to be held with participant, "Evaluation of Serum Electrolyte Imbalances in Geriatric Patients Undergoing Brain Surgery: A Prospective Randomized Observational Study" will be attempted. Participation in the research is completely voluntary. If participants want to at any time while the research is ongoing, participants can leave the research provided that participants inform the responsible researcher. Participants answering the questionnaire will be interpreted as giving your consent to participate in the research. The information received from participant during the research will be kept by the researcher and the collected data will be used only for scientific purposes.
Detailed description
It is a well-established that patients suffering from head trauma experience at least one electrolyte disturbance. However, it appears that intensive care nurses, who are of paramount importance in the care of these critically ill patients whose homeostasis is disrupted, do not possess the necessary knowledge and skills. The study purpose is to compare the serum electrolyte imbalances of surgical and non-surgical geriatric patients with brain injury and to draw attention to the importance of nursing care. This is a single center, a prospective observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery Group | – | –30 neurosurgical patients |
| Non-Surgery Group | – | –30 neurological patients |
Who may qualify
- Ages
- 65 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study group included geriatric patients: with and without surgery. G*Power software (version 3.1.9.7) was used for power analysis and 60 patients were included in the study. To ensure the relevance of the data, the study included patients within the first 24 hours after trauma and the first 24 hours of hospitalization. Neurological patients with or without neurosurgery, aged 65 years and older, who volunteered to participate were included in the study. Patients with chronic renal failure and heart failure using diuretics were not included in the study.
Key inclusion criteria (1 listed)
- To ensure the relevance of the data, the study included patients within the first 24 hours after trauma and the first 24 hours of hospitalization. Neurological patients with or without neurosurgery, aged 65 years and older, who volunteered to participate were included in the study.
Key exclusion criteria (1 listed)
- Patients with chronic renal failure and heart failure using diuretics were not included in the study.
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
The researcher's data form checklist
Time frame: August and October 2024
Data Form: The researcher's data form consisted of the sociodemographic characteristics of the participants (age, gender, chronic diseases, mechanism of injury) and clinical characteristics (surgical procedure, Glasgow Coma Scale score, ASA class, history of cardiopulmonary resuscitation, number of intubation days) of patients. Also, serum electrolyte values were monitored (blood glucose, alanine aminotransferase, aspartate aminotransferase, urea, creatinine, serum sodium, potassium, calcium, chloride, magnesium, serum phosphorus, and albumin). The patients and their relatives were interviewed after ethical approval and the necessary permissions from the institution where the study was conducted. The purpose and scope of the study were explained, and they were invited to participate. Their written consent was obtained. Once the patients were hospitalized in the neurology intensive care unit, the Personal Information Form was completed and recorded over five days.
1 secondary outcome
Glasgow Coma Scale (GCS)
Time frame: August-October 2024
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 9 Sep 2026.
- 3\. Gaab, M., Knoblich, O. E., Schupp., J, \& et al. (1979). Effect of furosemide on acute severe experimental cerebral edema. J Neurol, 220(3), 185-197.Link provided by the sponsor.
- 2\. Dey, S., Kumar, R., \& Tarat, A. (2021). Evaluation of electrolyte imbalance in patients with traumatic brain injury admitted in the central icu of a tertiary care centre: A prospective observational study. Cureus, 13(8), e17517.Link provided by the sponsor.
- 1\. Suner, H. I. (2020). Head trauma in the elderly. Turkish Neurosir Journal, 30(2), 293-299.Link provided by the sponsor.
- 4\. Suman, S., Kumar, N., Singh, Y., Kumar, V., Yadav, G., Gupta, B. K., Pandey, A. R., \& Pandey, S. (2016). Evaluation of serum electrolytes in traumatic brain injury patients: Prospective randomized observational study. Journal of Anesthesia \& CriticalLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Age Glasgow coma scale ASA class Number of intubated days Gender Mechanism of injury Surgical procedure Resuscitation Chronically ill Electrolyte values
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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 Brain Injury Traumatic Severe and Serum Concentrations, run by Zonguldak Bulent Ecevit University 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 1 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 9 Sep 2026. 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 researcher's data form checklist (time frame: August and October 2024). 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 9 Sep 2026.