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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05968066
Other study ID # PRoFLUID
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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