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Fluid Challenges in Intensive Care (FENICE)

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ClinicalTrials.gov Identifier: NCT01787071
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Guy FRANCOIS, European Society of Intensive Care Medicine

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

Condition or disease Intervention/treatment
Focus: Fluid Challenge Other: Fluid challenge

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Study Type : Observational
Actual Enrollment : 2304 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: How do we Administer Fluids in the ICU?
Study Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Group/Cohort Intervention/treatment
one group
Patients receiving fluid challebnge
Other: Fluid challenge
Administration of red blood cell transfusions or fresh frozen plasma is not considered as a fluid challenge.
Other Name: 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.




Primary Outcome Measures :
  1. Number of patients in whom functional hemodynamic variables are used to indicate fluid challenge. [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Number of patients responding to fluids, number of patients presenting contra-indication to functional hemodynamic variables. [ Time Frame: one week ]

Other Outcome Measures:
  1. number of patients responding to fluids according to time from admission in ICU [ Time Frame: one week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
criticallyill patients receiving fluid challenge
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787071


Locations
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Belgium
All Centres Willing to Contribute Are Welcome
Brussels, Belgium
Sponsors and Collaborators
European Society of Intensive Care Medicine
Investigators
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Principal Investigator: Daniel De Backer, MD,PhD Erasme University Hospital, Brussels
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guy FRANCOIS, ESICM Trials Group, European Society of Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT01787071    
Other Study ID Numbers: FENICE
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Guy FRANCOIS, European Society of Intensive Care Medicine:
fluids
crtically ill patients
functional hemodynamics
cvp