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Intravenous Fluid Practices in Turkish Intensive Care Units (TR-FLUID)

10 czerwca 2026 zaktualizowane przez: Ozkul Yilmaz Colak, Ondokuz Mayıs University

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.

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

400

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Adults present in participating Turkish adult ICUs at the index time on the study day

Opis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Younger than 18 years of age
  • Refusal of study participation by the patient or their legal representative

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Proportion of Patients Receiving Resuscitation Fluid and Distribution of Intravenous Fluid Types
Ramy czasowe: 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.
24 hours (study Day 1, 08:00 to study Day 2, 08:00)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Cumulative Sodium and Chloride Load by Indication
Ramy czasowe: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
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.
24 hours (study Day 1, 08:00 to study Day 2, 08:00)
24-Hour Cumulative Fluid Balance
Ramy czasowe: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
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).
24 hours (study Day 1, 08:00 to study Day 2, 08:00)
Distribution of Fluid Therapy Phase (ROSE Classification)
Ramy czasowe: Baseline (study Day 1) and 24 hours
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.
Baseline (study Day 1) and 24 hours
ICU and Hospital Mortality
Ramy czasowe: Up to 30 days
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.
Up to 30 days
New Vasopressor Initiation or Dose Increase Within 24 Hours
Ramy czasowe: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
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.
24 hours (study Day 1, 08:00 to study Day 2, 08:00)
New Acute Kidney Injury Within 24 Hours (KDIGO Criteria)
Ramy czasowe: 24 hours (study Day 1, 08:00 to study Day 2, 08:00)
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.
24 hours (study Day 1, 08:00 to study Day 2, 08:00)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2026

Ukończenie studiów (Szacowany)

1 września 2027

Daty rejestracji na studia

Pierwszy przesłany

5 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

16 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

Beginning 6 months after publication of the primary results and ending 36 months thereafter

Kryteria dostępu do udostępniania IPD

Approval of a methodologically sound proposal by the Steering Committee and a signed data-sharing agreement

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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