Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients

Recruiting

• Conditions: Invasive Ventilation; Vasopressor Therapy; Critical Illness; Fluid Therapy

• Registration Number: NCT05968066
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-08-01
• Study Start: 2023-12-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of various aspects of fluid therapy	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 Outcome Measures

Name	Time	Method
Types of vasopressors	seven days	The type (i.e. noradrenaline, vasopressin, adrenaline) of vasopressors that are prescribed
Timing of start of administered diuretics.	seven days	Time between start of invasive ventilation and administration of diuretics in days
Duration of diuretic therapy	seven days	In days
Incidence of atrial arrythmias	7 days
Duration of vasopressor therapy	seven days	In days
Concentration of types of vasopressors	seven days	The concentration (i.e. in µg/ml) of vasopressors that are prescribed per administration route
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	The type of diuretics that are prescribed
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	Timing of start of vasopressors from ICU admission in minutes per administration route (i.e. central versus peripheral)
Cumulative fluid balances	seven days

Trial Locations

Locations (1)

Amsterdam UMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands