Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients

Study Overview
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Brief Summary
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The goal of this woldwide observational study is to investigate various aspects of fluid and vasopressor therapy in critically ill invasively ventilated patients. The main questions it aims to answer are: What is the global current practice of fluid and vasopressor therapy? What are associations between this practice and clinical outcomes? Participating intensive care units will gather detailed information about fluid and vasopressor therapy prescribed to participants. Participating intensive care units will also gather information about participant outcomes such as duration of invasive ventilation, length of stay and mortality

Detailed Description
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Rationale: The worldwide practice of fluid and vasopressor therapy in critically ill invasively ventilated patients is uncertain. Indeed, it is unclear whether there is a difference in fluid and vasopressor therapy in these patients between Low- and Middle-income Countries (LMICs) and High-income Countries (HICs). Objective: To determine various aspects of fluid and vasopressor therapy in critically ill invasively ventilated patients in LMICs and HICs. Hypothesis: There is substantial worldwide variation in practice of fluid and vasopressor therapy in critically ill invasively ventilated patients. Study design: International, multicenter, observational study in critically ill invasively ventilated patients; data are captured during a predefined period per geographic region or country. Study population: Critically ill invasively ventilated patients. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts or electronic medical records systems is of no risk to the patients.

Official Title
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Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)--an International Multicenter Observational Cohort Study

Conditions
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Fluid Therapy, Vasopressor Therapy, Critical Illness, Invasive Ventilation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to a participating intensive care unit; Receiving invasive ventilation; and Duration of ventilation > 24 hours. Exclusion Criteria: Age < 16 years; Patients transferred under invasive ventilation from another intensive care unit.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of various aspects of fluid therapy | Including total volumes of types of fluids administered in the first three days after ICU admission and total volume of fluids infused in the first seven days of ICU admission | seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of start of continuous administration of vasopressors. | Timing of start of vasopressors from ICU admission in minutes per administration route (i.e. central versus peripheral) | seven days | 
| Duration of vasopressor therapy | In days | seven days | 
| Types of vasopressors | The type (i.e. noradrenaline, vasopressin, adrenaline) of vasopressors that are prescribed | seven days | 
| Concentration of types of vasopressors | The concentration (i.e. in µg/ml) of vasopressors that are prescribed per administration route | seven days | 
| Timing of start of administered diuretics. | Time between start of invasive ventilation and administration of diuretics in days | seven days | 
| Duration of diuretic therapy | In days | seven days | 
| Types of diuretics | The type of diuretics that are prescribed | seven days | 
| Bolus or continous infusion of diuretics |  | seven days | 
| Cumulative fluid balances |  | seven days | 
| Daily urine output |  | seven days | 
| Incidence of atrial arrythmias |  | 7 days | 
| Incidence of acute respiratory distress syndrome |  | 7 days | 
| Incidence of renal replacement therapy |  | 7 days | 
| Incidence of need for renal replacement therapy at ICU discharge. |  | 90 days | 
| Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid Therapy, Vasopressor, Resuscitation, Deresuscitation, Fluids