Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)--an International Multicenter Observational Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fluid Therapy
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 2508
- Locations
- 1
- Primary Endpoint
- Composite of various aspects of fluid therapy
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
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
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.
Investigators
Prof. Dr. Marcus J. Schultz
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Composite of various aspects of fluid therapy
Time Frame: seven days
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
Secondary Outcomes
- Types of vasopressors(seven days)
- Timing of start of administered diuretics.(seven days)
- Duration of diuretic therapy(seven days)
- Incidence of atrial arrythmias(7 days)
- Duration of vasopressor therapy(seven days)
- Concentration of types of vasopressors(seven days)
- Daily urine output(seven days)
- Incidence of need for renal replacement therapy at ICU discharge.(90 days)
- Bolus or continous infusion of diuretics(seven days)
- Incidence of acute respiratory distress syndrome(7 days)
- Types of diuretics(seven days)
- Incidence of renal replacement therapy(7 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)
- Timing of start of continuous administration of vasopressors.(seven days)
- Cumulative fluid balances(seven days)