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

NCT07649694 | Not Yet Recruiting

• 1 other identifier: TR-FLUID
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

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.

  24 hours (study Day 1, 08:00 to study Day 2, 08:00)

Secondary Outcomes (6)

• Cumulative Sodium and Chloride Load by Indication

  24 hours (study Day 1, 08:00 to study Day 2, 08:00)

• 24-Hour Cumulative Fluid Balance

  24 hours (study Day 1, 08:00 to study Day 2, 08:00)

• Distribution of Fluid Therapy Phase (ROSE Classification)

  Baseline (study Day 1) and 24 hours

• ICU and Hospital Mortality

  Up to 30 days

• New Vasopressor Initiation or Dose Increase Within 24 Hours

  24 hours (study Day 1, 08:00 to study Day 2, 08:00)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55002, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Özkul Yılmaz Çolak, MD

CONTACT

+905063349266; ozkulyilmaz.colak@omu.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, MD.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months after publication of the primary results and ending 36 months thereafter
• Access Criteria: Approval of a methodologically sound proposal by the Steering Committee and a signed data-sharing agreement

Locations

TU (1)