Intravenous Fluid Practices in Turkish Intensive Care Units (TR-FLUID)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOndokuz Mayıs University
About this trial
Intravenous (IV) fluids-fluids given directly into a vein-are among the most common treatments used in intensive care units (ICUs). They are given for several reasons, such as supporting blood pressure, providing daily water and salts, replacing losses, or diluting medications. However, the type of fluid, the amount given, and the salt (sodium and chloride) load can vary widely between hospitals and doctors. In Turkey, there is currently no up-to-date, multicenter information describing how IV fluids are used in adult ICUs in everyday practice.
This study, called TR-FLUID, aims to describe IV fluid use in adult ICUs across Turkey. It is an observational study, meaning the researchers only observe and record care that is already being provided. No extra tests, medications, or procedures are added, and the study does not change how patients are treated in any way.
On a single pre-selected study day at each participating ICU, the research team will identify all adult patients (18 years and older) who are in the ICU at 8:00 a.m. For each patient, the team will record the IV fluids given over the following 24 hours-including the fluid type, the volume, the reason it was given, and the resulting sodium and chloride load-together with the patient's fluid balance. All information is taken from the patient's existing medical records.
The main goal is to determine what proportion of patients receive fluids for resuscitation and which fluid types are used. The study will also describe the total fluid, sodium, and chloride given by indication; the 24-hour fluid balance; and how fluid use relates to short-term events such as the need for blood-pressure-supporting medications, new kidney injury, and ICU and hospital survival. These relationships will be explored to generate hypotheses and are not intended to prove cause and effect.
The findings will provide a national picture of current fluid practice in Turkish ICUs, help identify where practice differs from guidelines, and serve as a foundation for future quality-improvement and research efforts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older
Present in a participating intensive care unit at the index time (08:00 local time on the center's selected study day); no minimum or maximum ICU length of stay is required
Disqualifiers
Younger than 18 years of age
Refusal of study participation by the patient or their legal representative
Trial population
Adults present in participating Turkish adult ICUs at the index time on the study day
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 1 trial groupGroup A: Adult ICU Patients (Index-Day Cohort)
Trial outcomes
Primary outcomes
1
Proportion of Patients Receiving Resuscitation Fluid and Distribution of Intravenous Fluid Types
Among all enrolled patients, the proportion who receive at least one intravenous fluid given for a resuscitation indication during the 24-hour observation window, and the distribution of the administered fluid types (0.9% saline; balanced crystalloids \[Ringer's lactate, Isolyte-S, Plasma-Lyte 148\]; 5%/20% albumin; other colloids; hypertonic crystalloid). Reported as counts and percentages with 95% confidence intervals.
Time frame
24 hours (study Day 1, 08:00 to study Day 2, 08:00)Secondary outcomes
1
Cumulative Sodium and Chloride Load by Indication
Sodium load and chloride load (mmol), calculated from standard fluid composition tables, administered during the 24-hour observation window and summarized separately for each indication category (resuscitation, maintenance, replacement, and fluid creep). Reported as median and interquartile range.
Time frame
24 hours (study Day 1, 08:00 to study Day 2, 08:00)2
24-Hour Cumulative Fluid Balance
Net fluid balance (total intake minus total output, in mL) over the 24-hour observation window, reported as median and interquartile range and additionally categorized by threshold (\>0 mL, \>1 L, \>3 L).
Time frame
24 hours (study Day 1, 08:00 to study Day 2, 08:00)3
Distribution of Fluid Therapy Phase (ROSE Classification)
Proportion of patients in each phase of fluid therapy according to the ROSE conceptual model-Resuscitation, Optimization, Stabilization, and Evacuation (de-resuscitation)-classified at baseline (study Day 1) and reassessed at 24 hours. Reported as counts and percentages.
Time frame
Baseline (study Day 1) and 24 hours4
ICU and Hospital Mortality
ICU mortality (death before ICU discharge) and hospital mortality (death before hospital discharge, censored at day 30), reported as counts and percentages with 95% confidence intervals.
Time frame
Up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov
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