Electrolyte Imbalance in Surgical and Non-Surgical Geriatric Brain Injury Patients

NCT07809880 | Completed

• 1 other identifier: 2024-SBB-0614
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Brain Injury Traumatic Severe; Serum Concentrations; Nursing; Geriatric Patients

Keywords

Nursing; Geriatric patients; Serum concentrations; Brain injury traumatic severe

Outcome Measures

Primary Outcomes (1)

• 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.

  August and October 2024

Secondary Outcomes (1)

• Glasgow Coma Scale (GCS)

  August-October 2024

Study Arms (2)

Surgery Group

30 neurosurgical patients

Non-Surgery Group

30 neurological patients

Eligibility Criteria

• Age: 65 Years - 92 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with chronic renal failure and heart failure using diuretics were not included in the study.

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Atatürk State Hospital

Zonguldak, Center, 67030, Turkey (Türkiye)

Location

Related Links

• 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.
• 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.
• 1\. Suner, H. I. (2020). Head trauma in the elderly. Turkish Neurosir Journal, 30(2), 293-299.
• 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 \& Critical

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: September 9, 2026
• Study Start: August 25, 2024
• Primary Completion: September 25, 2024
• Study Completion: October 25, 2024
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: in 2025
• Access Criteria: Scientists

Locations

TU (1)