Focus: Fluid ChallengeFENICENCT01787071
Fluid Challenges in Intensive Care
An observational study of Focus: Fluid Challenge, run by European Society of Intensive Care Medicine at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focus: Fluid Challenge
- What is being tested?
- Fluid challenge
- How many people
- 2,304 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: criticallyill patients receiving fluid challenge
Who may be able to join
- 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
Who cannot join
- 1/ Patient already included in the trial
- 2/ Overt bleeding Patients younger than 18 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How do we Administer Fluids in the ICU?
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.
Read more
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?
- All patients enrolled in the study will receive standard clinical care
- Data will be collected in order to study how fluid challenges are performed in ICU's
- No extra tests will be performed for this study
- Only measurements and data available as part of clinical practice will be collected
Read the detailed description
Introduction
Fluid Administration in Critically Ill Patients.
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].
Fluids have beneficial impact on outcome, especially in the context of hemodynamic optimization. Haemodynamic optimization has been shown to improve patient outcome when applied in the perioperative period and in the early phases of septic shock [2,3]. On the other hand, a positive fluid balance is associated with a poor outcome [4,5], but this may just reflect patient severity. In patients with respiratory failure, once hemodynamically stable, fluid restriction is associated with earlier separation from mechanical ventilation [4]. Altogether, it seems reasonable to give just the amount of fluids needed when the patients is hemodynamically unstable and to restrict fluids when the patient is stabilized. Such an approach seems associated with better outcomes [6].
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
- 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.
Fluids in guidelines
Current guidelines on fluid administration that cover how to give fluids in all critically ill patients do not exist. In the surviving sepsis guidelines fluids are recommended in the very early phase of hemodynamic resuscitation of patients with severe sepsis[7]. At this stage it is recommended to administer these according to CVP [7]. In france, the use of functional hemodynamic tests (see below) is recommended in this setting [8]. After the initial phase, these guidelines are evasive on the way fluids should be guided.
In the UK there guidelines covering the administration of fluids in the perioperative setting. In the periopoerative setting in high risk surgical patients, guidelines recommend the use of fluids for stroke volume optimization {9} Apart from these specific settings, fluids administration is not covered in current guidelines.
Prediction of fluid responsiveness using Functional haemodynamic tests
Heart and Lung Interaction in fully mechanically ventilated patients During mechanical ventilation, increases in the intra-thoracic pressures induced by the inspiration, decrease the venous return to the right ventricle. If the right ventricle is 'volume' responsive, this results in a reduction in right ventricular stroke volume, which is subsequently translated through to a decreased left ventricular stroke volume, several beats later. This change in stroke volume (or stroke volume variation) can be detected by monitors that track real-time changes in stroke volume as a stroke volume variation.' When the two ventricles are working on the ascending part of the stroke volume/ventricular preload curve, then mechanical ventilation will induce changes in stroke volume which will be reflected, depending on the monitor used, in changes in stroke volume (Stroke Volume Variation, SVV), pulse pressure (Pulse Pressure Variation PPV), and systolic pressure (Systolic Pressure Variation, SPV). These are also called dynamic indices of preload because, by detecting these changes, they provide information on the preload reserve of the ventricles (fluid responsiveness). Therefore they can predict which patients may benefit from fluid administration prior to give fluids.
This has been widely studied with several monitors and proved to be effective in predicting fluid responsiveness with high sensitivity and specificity [10].
These techniques do have some limitations. In order to be reliable the patients need to be fully sedated and mechanically ventilated, with no spontaneous breathing activity and no arrhythmias. Also, as reported by De Backer et al. these indices lose power to predict fluid responsiveness in patients ventilated at volumes lower than 8 ml/kg [11].
Heart and Lung Interaction in spontaneously breathing patients
Passive leg raising is a maneuvre that produces an autologous fluid challenge by shifting venous blood from the legs to the intra-thoracic compartment. The response measured by a flow monitor is able to predict the response to a fluid challenge [12]. This has been studied with different monitors.
In the setting of spontaneously breathing patients Monge Garcia et al. have demonstrated that changes in pressure during a Valsalva manoeuvre predict fluid responsiveness (The Valsalva maneuvre is a forced expiration against a closed glottis) [13].
Summary of evidence
A summary of the evidence relating to use of fluids in the context of haemodynamic resuscitation suggests that:
- During the perioperative period and in the early phases of septic shock, the administration of targeted fluids to optimize pre-load provides an improvement in patient outcome.
- There is no evidence that protocols aimed at optimizing cardiac output are beneficial for the patient if not applied "early" or when oxygen debt has established.
- Observational studies have shown that a positive fluid balance is associated with an increased 60 day mortality.
- Despite this, patients who remain unstable after initial fluid resuscitation often receive fluids in an attempt to reverse their shock.
- Functional Haemodynamic tests have been developed to help the clinician in predicting the response to fluid administration.
- How the decisions of giving or not giving these fluids are made in different diseases, in different ICU's and in different countries is not known.
- How often functional haemodynamic tests are used is not known either.
- How the effects of fluids are monitored is not known either.
This study should give answers to points 6, 7 and 8. 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. The purpose of this study is to evaluate how fluids are administered
What does this study involve?
- All patients enrolled in the study will receive standard clinical care
- Data will be collected in order to study how fluid challenges are performed in ICU's
- No extra tests will be performed for this study
- Only measurements and data available as part of clinical practice will be collected
- Conditions
- Focus: Fluid Challenge
- Being tested
- Fluid challenge
- Keywords
- fluids, crtically ill patients, functional hemodynamics, cvp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challengeOther
Also called 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.
Administration of red blood cell transfusions or fresh frozen plasma is not considered as a fluid challenge.
| Study group | Role | What they receive |
|---|---|---|
| one group | Patients receiving fluid challebnge Receives: Other: Fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in whom functional hemodynamic variables are used to indicate fluid challenge.
Measured: 1 week
Secondary outcomes (1)
Number of patients responding to fluids, number of patients presenting contra-indication to functional hemodynamic variables.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focus: Fluid ChallengeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society of Intensive Care Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy FRANCOIS, European Society of Intensive Care Medicine
- Investigators
- Daniel De Backer, MD,PhD, Principal investigator, Erasme University Hospital, Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787071
- Sponsor's protocol ID
- FENICE
- Acronym
- FENICE
- Status last verified
- Aug 2014
- First submitted
- 4 Feb 2013
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26162676
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How do we Administer Fluids in the ICU?
- ClinicalTrials.gov ID
- NCT01787071
- Acronym / sponsor ID
- FENICE / FENICE
- Conditions
- Focus: Fluid Challenge
- Keywords
- fluids, crtically ill patients, functional hemodynamics, cvp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,304 participants (actual)
- Lead sponsor
- European Society of Intensive Care MedicineUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
- All patients enrolled in the study will receive standard clinical care
- Data will be collected in order to study how fluid challenges are performed in ICU's
- No extra tests will be performed for this study
- Only measurements and data available as part of clinical practice will be collected
Detailed description
Introduction
Fluid Administration in Critically Ill Patients.
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].
Fluids have beneficial impact on outcome, especially in the context of hemodynamic optimization. Haemodynamic optimization has been shown to improve patient outcome when applied in the perioperative period and in the early phases of septic shock [2,3]. On the other hand, a positive fluid balance is associated with a poor outcome [4,5], but this may just reflect patient severity. In patients with respiratory failure, once hemodynamically stable, fluid restriction is associated with earlier separation from mechanical ventilation [4]. Altogether, it seems reasonable to give just the amount of fluids needed when the patients is hemodynamically unstable and to restrict fluids when the patient is stabilized. Such an approach seems associated with better outcomes [6].
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
- 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.
Fluids in guidelines
Current guidelines on fluid administration that cover how to give fluids in all critically ill patients do not exist. In the surviving sepsis guidelines fluids are recommended in the very early phase of hemodynamic resuscitation of patients with severe sepsis[7]. At this stage it is recommended to administer these according to CVP [7]. In france, the use of functional hemodynamic tests (see below) is recommended in this setting [8]. After the initial phase, these guidelines are evasive on the way fluids should be guided.
In the UK there guidelines covering the administration of fluids in the perioperative setting. In the periopoerative setting in high risk surgical patients, guidelines recommend the use of fluids for stroke volume optimization {9} Apart from these specific settings, fluids administration is not covered in current guidelines.
Prediction of fluid responsiveness using Functional haemodynamic tests
Heart and Lung Interaction in fully mechanically ventilated patients During mechanical ventilation, increases in the intra-thoracic pressures induced by the inspiration, decrease the venous return to the right ventricle. If the right ventricle is 'volume' responsive, this results in a reduction in right ventricular stroke volume, which is subsequently translated through to a decreased left ventricular stroke volume, several beats later. This change in stroke volume (or stroke volume variation) can be detected by monitors that track real-time changes in stroke volume as a stroke volume variation.' When the two ventricles are working on the ascending part of the stroke volume/ventricular preload curve, then mechanical ventilation will induce changes in stroke volume which will be reflected, depending on the monitor used, in changes in stroke volume (Stroke Volume Variation, SVV), pulse pressure (Pulse Pressure Variation PPV), and systolic pressure (Systolic Pressure Variation, SPV). These are also called dynamic indices of preload because, by detecting these changes, they provide information on the preload reserve of the ventricles (fluid responsiveness). Therefore they can predict which patients may benefit from fluid administration prior to give fluids.
This has been widely studied with several monitors and proved to be effective in predicting fluid responsiveness with high sensitivity and specificity [10].
These techniques do have some limitations. In order to be reliable the patients need to be fully sedated and mechanically ventilated, with no spontaneous breathing activity and no arrhythmias. Also, as reported by De Backer et al. these indices lose power to predict fluid responsiveness in patients ventilated at volumes lower than 8 ml/kg [11].
Heart and Lung Interaction in spontaneously breathing patients
Passive leg raising is a maneuvre that produces an autologous fluid challenge by shifting venous blood from the legs to the intra-thoracic compartment. The response measured by a flow monitor is able to predict the response to a fluid challenge [12]. This has been studied with different monitors.
In the setting of spontaneously breathing patients Monge Garcia et al. have demonstrated that changes in pressure during a Valsalva manoeuvre predict fluid responsiveness (The Valsalva maneuvre is a forced expiration against a closed glottis) [13].
Summary of evidence
A summary of the evidence relating to use of fluids in the context of haemodynamic resuscitation suggests that:
- During the perioperative period and in the early phases of septic shock, the administration of targeted fluids to optimize pre-load provides an improvement in patient outcome.
- There is no evidence that protocols aimed at optimizing cardiac output are beneficial for the patient if not applied "early" or when oxygen debt has established.
- Observational studies have shown that a positive fluid balance is associated with an increased 60 day mortality.
- Despite this, patients who remain unstable after initial fluid resuscitation often receive fluids in an attempt to reverse their shock.
- Functional Haemodynamic tests have been developed to help the clinician in predicting the response to fluid administration.
- How the decisions of giving or not giving these fluids are made in different diseases, in different ICU's and in different countries is not known.
- How often functional haemodynamic tests are used is not known either.
- How the effects of fluids are monitored is not known either.
This study should give answers to points 6, 7 and 8. 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. The purpose of this study is to evaluate how fluids are administered
What does this study involve?
- All patients enrolled in the study will receive standard clinical care
- Data will be collected in order to study how fluid challenges are performed in ICU's
- No extra tests will be performed for this study
- Only measurements and data available as part of clinical practice will be collected
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | – | Other: Fluid challengePatients receiving fluid challebnge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- criticallyill patients receiving fluid challenge
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 1/ Patient already included in the trial
- 2/ Overt bleeding Patients younger than 18 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid challengeAlso: 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.Administration of red blood cell transfusions or fresh frozen plasma is not considered as a fluid challenge. | Other | one group |
Primary outcome
Number of patients in whom functional hemodynamic variables are used to indicate fluid challenge.
Time frame: 1 week
1 secondary outcome
Number of patients responding to fluids, number of patients presenting contra-indication to functional hemodynamic variables.
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Derived from this study: PubMed 26162676Cecconi 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.
- ECCRN webpageLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel De Backer, MD,PhD principal investigator
Erasme University Hospital, Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus: Fluid Challenge, run by European Society of Intensive Care Medicine at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in whom functional hemodynamic variables are used to indicate fluid challenge. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01787071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.