Critical IllnessNCT07649694
Intravenous Fluid Practices in Turkish Intensive Care Units (TR-FLUID)
An observational study of Critical Illness and Fluid Therapy, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Fluid Therapy, Practices
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults present in participating Turkish adult ICUs at the index time on the study day
Who may be able to join
- 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
Who cannot join
- Younger than 18 years of age
- Refusal of study participation by the patient or their legal representative
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55002
Melda ISEVI, MD, +905444202552, drmeldaisevi@gmail.com
About this study
Official title: TR-FLUID: Evaluation of Intravenous Fluid Administration Practices in Turkish Intensive Care Units: A Multicenter, Prospective, Point-Prevalence Observational Study
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.
Read more
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.
Read the detailed description
TR-FLUID is a multicenter, prospective, point-prevalence observational study of intravenous (IV) fluid practice in adult intensive care units (ICUs) in Turkey. The design follows the methodology of the international SAFE-TRIPS and Fluid-TRIPS point-prevalence studies but extends it in three ways: (1) it captures all four indications for fluid therapy-resuscitation, maintenance, replacement, and fluid creep (hidden fluids such as drug diluents and line-patency fluids)-rather than resuscitation alone; (2) it classifies each patient by the phase of fluid therapy using the ROSE conceptual model (Resuscitation, Optimization, Stabilization, Evacuation); and (3) it collects detailed center-level contextual data, including the locally available fluid portfolio, the presence of a written fluid protocol, intensivist coverage, and who orders the fluids.
Sampling and data window: Each participating ICU selects one of four pre-specified alternative study days, distributed across calendar quarters and across weekdays/weekends to balance seasonal and weekly effects. The index time is defined as 08:00 local time on the chosen day. All eligible patients present in the ICU at the index time are screened and enrolled. For each patient, every IV fluid administered during the 24-hour prospective observation window (08:00 to 08:00 the next day) is recorded, including generic/brand name, volume, route, indication category, and start/stop time. Cumulative fluid balance and cumulative albumin received from ICU admission up to the index time are recorded retrospectively from the hospital information system. The sodium, chloride, and glucose load of each fluid is calculated from standard composition tables.
Multicenter organization: The study is coordinated from Ondokuz Mayıs University. Following coordinating-center ethics approval, an open call is issued to adult ICUs across Turkey through scientific societies and direct contact. Each participating center obtains its own local institutional approval before collecting any data; no center collects data without institutional permission. Each center designates a local investigator responsible for screening, the written informed consent process, and data entry. Written informed consent is obtained from each patient or, for patients unable to provide consent, from a legal representative.
Data collection and standardization: Data are entered through two standardized electronic instruments-a Center Information Form (completed once per center) and a Patient Case Report Form (completed per patient). Before data collection begins, all centers attend an online training session and receive a written operations manual and operational definitions covering fluid-type and indication categorization, ROSE phase assignment, norepinephrine-equivalent dose calculation, and KDIGO acute kidney injury staging. A one-day pilot is conducted at the coordinating center to refine the instruments.
Data management and analysis: Each patient is assigned a center-based unique study identifier; no patient identifiers are transmitted to the coordinating center. Data are stored in an access-restricted, encrypted database subject to automated range and logical-consistency checks and manual verification, with data queries returned to centers for missing or implausible values. Data management complies with the Turkish Personal Data Protection Law (KVKK) and the Declaration of Helsinki, and the study is reported in accordance with the STROBE statement. Statistical analyses are performed using IBM SPSS Statistics. Descriptive results are presented with 95% confidence intervals; determinants of fluid choice are explored using mixed-effects models with center as a random effect, and between-center variability is assessed using the intraclass correlation coefficient and median odds ratio. All association analyses are hypothesis-generating and make no causal claims.
- Conditions
- Critical Illness, Fluid Therapy, Practices
- Keywords
- TR-FLUID, Intravenous fluid therapy, Fluid resuscitation, Resuscitation fluid, Balanced crystalloids, Normal saline, Albumin, Fluid creep, Maintenance fluids, Fluid balance, Chloride load, Fluid stewardship, Critical care
- Medical subject headings
- Critical Illness
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 |
|---|---|---|
| Adult ICU Patients (Index-Day Cohort) | All adult patients (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. This single observational cohort is followed prospectively for 24 hours, during which all intravenous fluids administered as part of routine clinical care are recorded by indication (resuscitation, maintenance, replacement, and fluid creep) together with fluid balance and sodium/chloride load. No study intervention is applied; intravenous fluid therapy is observed exactly as ordered by the treating team. Patients are then followed for ICU mortality until ICU discharge and for hospital mortality until discharge or censored at day 30. No minimum or maximum ICU length of stay is required for inclusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
Secondary outcomes (6)
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.
Measured: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
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).
Measured: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
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.
Measured: Baseline (study Day 1) and 24 hours
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.
Measured: Up to 30 days
New Vasopressor Initiation or Dose Increase Within 24 Hours
Proportion of patients in whom a new vasopressor is started, or an existing vasopressor dose is increased (expressed as norepinephrine-equivalent dose, µg/kg/min), during the 24-hour observation window. Reported as counts and percentages.
Measured: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
New Acute Kidney Injury Within 24 Hours (KDIGO Criteria)
Proportion of patients who develop new acute kidney injury during the 24-hour window, defined by KDIGO serum creatinine and/or urine output criteria (KDIGO stage 0 at the index time progressing to stage ≥1 at 24 hours), with the maximum KDIGO stage reported. Reported as counts and percentages.
Measured: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozkul Yilmaz Colak, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649694
- Sponsor's protocol ID
- TR-FLUID
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the published results will be available to qualified investigators upon reasonable request. Data to be shared include the de-identified analytic dataset for the published primary and secondary outcomes. Requests will be reviewed by the study Steering Committee and granted after approval of a methodologically sound proposal and execution of a data-sharing agreement, in compliance with the Turkish Personal Data Protection Law (KVKK) and the Declaration of Helsinki. No data containing patient identifiers will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TR-FLUID: Evaluation of Intravenous Fluid Administration Practices in Turkish Intensive Care Units: A Multicenter, Prospective, Point-Prevalence Observational Study
- ClinicalTrials.gov ID
- NCT07649694
- Acronym / sponsor ID
- TR-FLUID
- Conditions
- Critical Illness, Fluid Therapy, Practices
- Keywords
- TR-FLUID, Intravenous fluid therapy, Fluid resuscitation, Resuscitation fluid, Balanced crystalloids, Normal saline, Albumin, Fluid creep
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 16 Jun 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.
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.
Detailed description
TR-FLUID is a multicenter, prospective, point-prevalence observational study of intravenous (IV) fluid practice in adult intensive care units (ICUs) in Turkey. The design follows the methodology of the international SAFE-TRIPS and Fluid-TRIPS point-prevalence studies but extends it in three ways: (1) it captures all four indications for fluid therapy-resuscitation, maintenance, replacement, and fluid creep (hidden fluids such as drug diluents and line-patency fluids)-rather than resuscitation alone; (2) it classifies each patient by the phase of fluid therapy using the ROSE conceptual model (Resuscitation, Optimization, Stabilization, Evacuation); and (3) it collects detailed center-level contextual data, including the locally available fluid portfolio, the presence of a written fluid protocol, intensivist coverage, and who orders the fluids.
Sampling and data window: Each participating ICU selects one of four pre-specified alternative study days, distributed across calendar quarters and across weekdays/weekends to balance seasonal and weekly effects. The index time is defined as 08:00 local time on the chosen day. All eligible patients present in the ICU at the index time are screened and enrolled. For each patient, every IV fluid administered during the 24-hour prospective observation window (08:00 to 08:00 the next day) is recorded, including generic/brand name, volume, route, indication category, and start/stop time. Cumulative fluid balance and cumulative albumin received from ICU admission up to the index time are recorded retrospectively from the hospital information system. The sodium, chloride, and glucose load of each fluid is calculated from standard composition tables.
Multicenter organization: The study is coordinated from Ondokuz Mayıs University. Following coordinating-center ethics approval, an open call is issued to adult ICUs across Turkey through scientific societies and direct contact. Each participating center obtains its own local institutional approval before collecting any data; no center collects data without institutional permission. Each center designates a local investigator responsible for screening, the written informed consent process, and data entry. Written informed consent is obtained from each patient or, for patients unable to provide consent, from a legal representative.
Data collection and standardization: Data are entered through two standardized electronic instruments-a Center Information Form (completed once per center) and a Patient Case Report Form (completed per patient). Before data collection begins, all centers attend an online training session and receive a written operations manual and operational definitions covering fluid-type and indication categorization, ROSE phase assignment, norepinephrine-equivalent dose calculation, and KDIGO acute kidney injury staging. A one-day pilot is conducted at the coordinating center to refine the instruments.
Data management and analysis: Each patient is assigned a center-based unique study identifier; no patient identifiers are transmitted to the coordinating center. Data are stored in an access-restricted, encrypted database subject to automated range and logical-consistency checks and manual verification, with data queries returned to centers for missing or implausible values. Data management complies with the Turkish Personal Data Protection Law (KVKK) and the Declaration of Helsinki, and the study is reported in accordance with the STROBE statement. Statistical analyses are performed using IBM SPSS Statistics. Descriptive results are presented with 95% confidence intervals; determinants of fluid choice are explored using mixed-effects models with center as a random effect, and between-center variability is assessed using the intraclass correlation coefficient and median odds ratio. All association analyses are hypothesis-generating and make no causal claims.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult ICU Patients (Index-Day Cohort) | – | –All adult patients (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. This single observational cohort is followed prospectively for 24 hours, during which all intravenous fluids administered as part of routine clinical care are recorded by indication (resuscitation, maintenance, replacement, and fluid creep) together with fluid balance and sodium/chloride load. No study intervention is applied; intravenous fluid therapy is observed exactly as ordered by the treating team. Patients are then followed for ICU mortality until ICU discharge and for hospital mortality until discharge or censored at day 30. No minimum or maximum ICU length of stay is required for inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults present in participating Turkish adult ICUs at the index time on the study day
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Younger than 18 years of age
- Refusal of study participation by the patient or their legal representative
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
Proportion of Patients Receiving Resuscitation Fluid and Distribution of Intravenous Fluid Types
Time frame: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
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.
6 secondary outcomes
Cumulative Sodium and Chloride Load by Indication
Time frame: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
24-Hour Cumulative Fluid Balance
Time frame: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
Distribution of Fluid Therapy Phase (ROSE Classification)
Time frame: Baseline (study Day 1) and 24 hours
ICU and Hospital Mortality
Time frame: Up to 30 days
New Vasopressor Initiation or Dose Increase Within 24 Hours
Time frame: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
New Acute Kidney Injury Within 24 Hours (KDIGO Criteria)
Time frame: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the published results will be available to qualified investigators upon reasonable request. Data to be shared include the de-identified analytic dataset for the published primary and secondary outcomes. Requests will be reviewed by the study Steering Committee and granted after approval of a methodologically sound proposal and execution of a data-sharing agreement, in compliance with the Turkish Personal Data Protection Law (KVKK) and the Declaration of Helsinki. No data containing patient identifiers will be shared.
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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.
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 Critical Illness and Fluid Therapy, run by Ondokuz Mayıs 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 16 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özkul Yılmaz Çolak, MD (+905063349266, ozkulyilmaz.colak@omu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Receiving Resuscitation Fluid and Distribution of Intravenous Fluid Types (time frame: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)). 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 16 Jun 2026.