Fluid Challenges in Intensive Care

NCT01787071 | Completed

• 1 other identifier: FENICE
• Study Type: observational
• Target: 2,304
• Locations: 1 country
• Sites: 1

Brief Summary

Fluids are one of most common therapies used in critically ill patients. Fluids are the cornerstone of hemodynamic management. In overt bleeding, fluids are often given without guidance with specific haemodynamic monitoring. In other conditions when hypovolemia may be more subtle or when the response to fluids is more variable, fluids are often given in a more titrable way, monitoring their haemodynamic impact. This practice, called the fluid challenge technique has been proposed by Max Harry Weil more than 30 years ago \[1\]. The fluid challenge has been used in several papers and studies assessing the response of patients to fluids. The way this practice is performed varies in terms of type of fluid, volume of fluid, rate of fluid administration, and clinical endpoints used. There is no data that describe how fluid challenges are administered in ICU's across the world. Understanding this will provide valuable information regarding current practice and would be a basis for improving current practice and future research. The way fluids are administered vary widely. Indications for fluids and monitoring of the effects are not standardized and may thus lead to heterogeneity in practice. In addition, several patients may fail to respond to fluids. The purpose of this observational study is to evaluate how fluids are administered and to identify the factors associated with a positive response to fluids. Better characterizing these practices and the patients who benefit from fluids would set the basis of further interventional trials trying to optimize fluid administration. What does this study involve?

1. 1.All patients enrolled in the study will receive standard clinical care
2. 2.Data will be collected in order to study how fluid challenges are performed in ICU's
3. 3.No extra tests will be performed for this study
4. 4.Only measurements and data available as part of clinical practice will be collected

Conditions

Focus: Fluid Challenge

Keywords

fluids; crtically ill patients; functional hemodynamics; cvp

Outcome Measures

Primary Outcomes (1)

• Number of patients in whom functional hemodynamic variables are used to indicate fluid challenge.

  1 week

Secondary Outcomes (1)

• Number of patients responding to fluids, number of patients presenting contra-indication to functional hemodynamic variables.

  one week

Other Outcomes (1)

• number of patients responding to fluids according to time from admission in ICU

  one week

Study Arms (1)

one group

Patients receiving fluid challebnge

Other: Fluid challenge

Interventions

Fluid challenge OTHER

Administration of red blood cell transfusions or fresh frozen plasma is not considered as a fluid challenge.

Also known as: For the purpose of this study a fluid challenge is defined as administration of any bolus of fluid (crystalloid or colloid) in less than two hours.

one group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

criticallyill patients receiving fluid challenge

You may qualify if:

• All consecutive adult (18 years old and above) patients , up to a maximum of 20, in whom a fluid challenge is performed during a one week period will be included

You may not qualify if:

• / Patient already included in the trial
• / Overt bleeding Patients younger than 18 year

Sponsors & Collaborators

• European Society of Intensive Care Medicine: lead

Study Sites (1)

All Centres Willing to Contribute Are Welcome

Brussels, Belgium

Location

Related Publications (1)

• Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.

  PMID: 26162676 DERIVED

Related Links

• ECCRN webpage

MeSH Terms

Interventions

Crystalloid Solutions; Colloids

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations; Complex Mixtures; Dosage Forms

Study Officials

• Daniel De Backer, MD,PhD

  Erasme University Hospital, Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ESICM Trials Group

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 8, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

BE (1)