ICU Fluid Utilization Survey in Southeast Asia

Critical Illness Clinical Trial

— Fluid-SEA  

Official title:

ICU Fluid Utilization Survey in Southeast Asia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06034990
• Other study ID #: IRB.457/66
• Status: Recruiting
• Start date: January 31, 2024
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Chulalongkorn University
• Contact: Nattapakorn Mai-on, MD
• Phone: +66970051116
• Email: naphtmaryx[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to examine the use of different types of fluids for resuscitation in different phases of fluid management in 3 types of critically ill patients including (1) not bleeding, not septic but need volume resuscitation (representing normal condition), (2) bleeding but not septic (representing normal vascular integrity but with a loss of intravascular colloids), (3) septic (representing the condition with increase vascular permeability and endothelium damage) in the ICU within Southeast Asia.

The data are collected by a 10-min online survey administered to included physicians which will be distributed via multiple online channels through representatives of each countries.

Description:

The objective of this study is to examine the use of different types of fluids for resuscitation in different phases of fluid management in 3 types of critically ill patients including (1) not bleeding, not septic but need volume resuscitation (representing normal condition), (2) bleeding but not septic (representing normal vascular integrity but with a loss of intravascular colloids), (3) septic (representing the condition with increase vascular permeability and endothelium damage) in the ICU within Southeast Asia, and to determine whether co-morbidities with hypoalbuminemia, clinician specialties, hospital practice settings, geographic locations and re-imbursement limitation especially for colloids influence the practice patterns of fluid utilization in different phases in the 3 types of patients. Ultimately, the information provided by this study could also provide basic background information for the design of future clinical trials regarding fluid resuscitation strategies.

The data are collected by a 10-min online survey administered to included physicians which will be distributed via multiple online channels through representatives of each countries.

The survey will start with an inform-consent form prior to starting the survey questions which consist of 13-item questionnaire obtaining information on

1. Demographics data of clinicians taking the survey on primary specialty, region or country of practice and hospital settings.

2. Preferences for volume status indicators.

3. Preferences for fluid resuscitation in 3 types of patients (1. Septic 2. bleeding but not septic 3. not bleeding and not septic) during resuscitation and optimization phase.

4. Preferences for fluid resuscitation in the 3 types of patients with hypoalbuminemia including (1) cirrhosis (2) nephrotic syndrome (3) other significant hypoalbuminemia during resuscitation/optimization phase and stabilization phase

5. The reasons for using colloids for volume expansion

6. The experience of adverse reactions to albumin

7. The awareness and importance of non-oncotic properties of albumin

8. The impact of reimbursement for colloids on resuscitation fluid choice

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Specialty must be in Anesthesiology, Surgery, Critical Care Medicine, Pulmonology, Nephrology, Internal Medicine, General Practitioner

2. Practice must be in Southeast Asia hospitals

3. Must work in Surgical ICU, Medical ICU , and/or Mixed ICU

Exclusion Criteria:

1.Physicians who worked in cardiac, neurology or pediatric ICUs

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• 10-min online survey
This is a cross-sectional study. The data are collected by a 10-min online survey administered to included physicians which will be distributed via online channels such as such as official website or Facebook pages of Society of intensive care or Society of nephrology of corresponding countries.

Locations

Country	Name	City	State
Thailand	Chulalongkorn university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Miller TE, Bunke M, Nisbet P, Brudney CS. Fluid resuscitation practice patterns in intensive care units of the USA: a cross-sectional survey of critical care physicians. Perioper Med (Lond). 2016 Jun 16;5:15. doi: 10.1186/s13741-016-0035-2. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid resuscitation practice pattern	Preferences for fluid resuscitation in 3 types of patients (1. Septic 2. bleeding but not septic 3. not bleeding and not septic) during resuscitation and optimization phase.	1/9/23-1/9/24
Secondary	Preferences for volume status indicators.	Preferences for volume status indicators and diagnostic tools	1/9/23-1/9/24
Secondary	Fluid resuscitation practice pattern in hypoalbuminemic state	Preferences for fluid resuscitation in the 3 types of patients with hypoalbuminemia including (1) cirrhosis (2) nephrotic syndrome (3) other significant hypoalbuminemia during resuscitation/optimization phase and stabilization phase	1/9/23-1/9/24