Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients

Critical Illness Clinical Trial

— PRoFLUID  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05968066
• Other study ID #: PRoFLUID
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Siebe G. Blok, MD
• Phone: 020 566 9111
• Email: siebeblok[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Fluid Therapy
• Invasive Ventilation

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Amsterdam UMC, location VUmc, Mahidol Oxford Tropical Medicine Research Unit, University Hospital, Antwerp

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pre-defined subgroup analysis in patients admitted with burns	All aforementioned outcomes in patients with burns	90 days
Other	Pre-defined subgroup analysis in patients admitted with acute respiratory distress syndrome	All aforementioned outcomes in patients with acute respiratory distress syndrome	90 days
Other	Pre-defined subgroup analysis in patients admitted with sepsis	All aforementioned outcomes in patients with sepsis	90 days
Primary	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	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
Secondary	Duration of vasopressor therapy	In days	seven days
Secondary	Types of vasopressors	The type (i.e. noradrenaline, vasopressin, adrenaline) of vasopressors that are prescribed	seven days
Secondary	Concentration of types of vasopressors	The concentration (i.e. in µg/ml) of vasopressors that are prescribed per administration route	seven days
Secondary	Timing of start of administered diuretics.	Time between start of invasive ventilation and administration of diuretics in days	seven days
Secondary	Duration of diuretic therapy	In days	seven days
Secondary	Types of diuretics	The type of diuretics that are prescribed	seven days
Secondary	Bolus or continous infusion of diuretics		seven days
Secondary	Cumulative fluid balances		seven days
Secondary	Daily urine output		seven days
Secondary	Incidence of atrial arrythmias		7 days
Secondary	Incidence of acute respiratory distress syndrome		7 days
Secondary	Incidence of renal replacement therapy		7 days
Secondary	Incidence of need for renal replacement therapy at ICU discharge.		90 days
Secondary	Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital		90 days