Fluid ShiftsPOINCARENCT02765009
Effects of Fluid Balance Control in Critically Ill Patients
A study testing diuretics, albumin and fluid restriction in people with Fluid Shifts and Critical Care, run by Central Hospital, Nancy, France at 11 sites in France.
Trial summary
Most ICU patients develop a positive fluid balance, mainly during the two first weeks of their stay. The causes are multifactorial: a reduced urine output subsequent to shock state, positive pressure mechanical ventilation, acute renal failure, post-operative period of major surgical procedures, and simultaneous fluid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Shifts, Critical Care
- What is being tested?
- diuretics, albumin and fluid restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,411 participants
- Where
- 11 sitesFrance
- Study dates
- 1 Jun 2016to 25 May 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patients under mechanical ventilation, admitted for > 48h and <72h and no discharge planned for the next 24h
Who cannot join
- Age < 18 years
- Failure to weigh the patient
- Multiple trauma
- Transfer from another ICU with a previous stay > 24h
- High probability of withdrawing treatment for ethical purposes within 7 days
- Pregnancy
- Patient refusal
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Hopital Nord Franche-Comté
Belfort, 90000
Centre Hospitalier Universitaire
Dijon, 21000
Centre Hospitalier Universitaire
Lyon, 69000
Centre Hospitalier Régional
Metz, 57000
Centre Hospitalier Régional et Universitaire
Nancy, 54000
Groupe Hospitalier Saint Joseph
Paris, 75000
Centre Hospitalier intercommunal
Poissy, 78303
Centre Hospitalier Régional et Universitaire
Strasbourg, 67000
CentreHospitalier Régional et universitaire
Strasbourg, 67000
Centre Hospitalier Régional
Thionville, 57000
Centre Hospitalier
Verdun, 55100
About this study
Official title: Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study
Most ICU patients develop a positive fluid balance, mainly during the two first weeks of their stay. The causes are multifactorial: a reduced urine output subsequent to shock state, positive pressure mechanical ventilation, acute renal failure, post-operative period of major surgical procedures, and simultaneous fluid loading to maintain volemia and acceptable arterial pressure. Additionally, the efficacy of fluid loading is frequently suboptimal, in relation to severe hypoalbuminemia and inflammatory capillary leakage. This results usually in a cumulated positive fluid balance of more than 10 litres at the end of the first week of stay. A high number of studies have showed that such a positive fluid balance was an independent factor of worse prognosis in selected populations of ICU patients: acute renal failure, acute respiratory distress syndrome (ARDS), sepsis, post-operative of high risk surgery. However, little is known about the putative causal role of positive fluid balance by itself on outcome. However, in two randomized controlled studies in patients with ARDS, a strategy of fluid balance control has been demonstrated to reduce time under mechanical ventilation and ICU length of stay with no noticeable adverse effects. Although avoiding fluid overload is now recommended in ARDS management, there is no evidence that this approach would be beneficial in a more general population of ICU patients (i.e. with sepsis, acute renal failure, mechanical ventilation). In addition, fluid restriction -mainly if applied early could be deleterious in reducing both tissue oxygen delivery and perfusion pressure. There is a place for a prospective study comparing a "conventional" attitude based on liberal fluid management throughout the ICU stay with a restrictive approach aiming at controlling fluid balance, at least as soon as the patient circulatory status is stabilized. The latter approach would use a simple algorithm using fluid restriction and diuretics based on daily weighing, a common procedure in the ICU, probably more reliable than cumulative measurement of fluid movements in patients whose limits have been underlined.
- Conditions
- Fluid Shifts, Critical Care
- Being tested
- diuretics, albumin, fluid restriction, renal replacement
- Keywords
- Fluid overload, Multiple organ failure, Diuretics, Fluid restriction, Body weight
- Medical subject headings
- Edema, Multiple Organ Failure, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diureticsDrug
Also called hydrochlorothiazide, bumetanide, furosemide
Used to reduce fluid overload as evidenced by weight gain
albuminDrug
Used to reduce fluid overload in addition with diuretics in hypoalbuminemic patients
fluid restrictionOther
Used to reduce fluid overload
renal replacementDevice
Also called ultrafiltration
Used to reduce fluid overload in patients with renal replacement
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care provided according to the ward policy. Patients have to be weighed at least on admission (day 0), day 7 and day 14. |
| Strategy | Experimental | Patients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement) Receives: Drug: diuretics; Drug: albumin; Other: fluid restriction; Device: renal replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at 60 days after inclusion
Vital status collected 60 days after admission; if the patient was dead at the time of assessment, date of death was collected
Measured: 60 days
Secondary outcomes (12)
Fluid balance control at day 7
Mean differences of patient body weight between Day 7 and admission (Day 0)
Measured: 7 days
Fluid balance control at day 14
Mean differences of patient body weight between Day 14 and admission (Day 0)
Measured: 14 days
All-cause mortality at 28-day after inclusion
Vital status collected 28 days after admission
Measured: 28 days
All-cause in-hospital mortality
Death during the hospital stay where the patient was included in the study
Measured: Up to 24 weeks
All-cause mortality at 365 days after inclusion
Vital status collected one year after admission
Measured: 365 days
Survival time period at Day 60
Time-related mortality, calculated from admission to the date of death
Measured: 60 days
Survival time period at Day 365
Time-related mortality, calculated from admission to the date of death
Measured: 365 days
Global end-organ damage assessment
Time-related changes of Sequential Organ Failure Assessment (SOFA score): SOFA is a score of organ failure with 6 subscales on organ dysfunction: respiratory, neurological, cardiovascular,hepatic,renal and coagulation. Each ranges from 0 to 4 and the total SOFA score is the sum of each subscale ; increasing severity from 0 (normal) to 24(moribund). Values of SOFA score are tightly correlated with mortality.
Measured: 28 days
Dependence on vasopressor drugs
Cumulated number of vasopressor-free days alive from day 0 to day 28
Measured: 28 days
Dependence on mechanical ventilation
Cumulated number of ventilator-free days alive from day 0 to day 28
Measured: 28 days
Dependence on renal replacement therapy
Cumulated number of renal replacement-free days alive from day 0 to day 60
Measured: 60 days
Cumulated number of pre-defined adverse events
Pre-defined adverse events include Systolic arterial pressure< 90 mm Hg, kalemia < 2,8 ,mmol/L, natremia >155 mmol/L, "injury" level of renal dysfunction (RIFLE scale), acute ischemic events (myocardial infarction, mesenteric ischemia)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start1 Jun 2016
- Primary completion31 Jul 2019
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fluid ShiftsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- El Mehdi Siaghy, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765009
- Sponsor's protocol ID
- 2015-A00662-47
- Acronym
- POINCARE
- Status last verified
- Sep 2020
- First submitted
- 29 Apr 2016
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agrinier N, Monnier A, Argaud L, Bemer M, Virion JM, Alleyrat C, Charpentier C, Ziegler L, Louis G, Bruel C, Jamme M, Quenot JP, Badie J, Schneider F, Bollaert PE. Effect of fluid balance control in critically ill patients: Design of the stepped wedge trial POINCARE-2. Contemp Clin Trials. 2019 Aug;83:109-116. doi: 10.1016/j.cct.2019.06.020. Epub 2019 Jun 29.
PubMed 31260794Buzzi M, Ricci L, Gibot S, Argaud L, Badie J, Bruel C, Charpentier C, Outin H, Louis G, Monnier A, Quenot JP, Schneider F, Minary L, Agrinier N. Implementation of a fluid balance control strategy in critically ill patients: POINCARE-2 trial process evaluation. BMC Med Res Methodol. 2024 Jul 24;24(1):160. doi: 10.1186/s12874-024-02288-1.
PubMed 39048932Mansouri A, Buzzi M, Gibot S, Charpentier C, Schneider F, Louis G, Outin H, Monnier A, Quenot JP, Badie J, Argaud L, Bruel C, Soudant M, Agrinier N; the POINCARE-2 group. Fluid balance control in critically ill patients: results from as-treated analyses of POINCARE-2 randomized trial. Crit Care. 2023 Nov 6;27(1):426. doi: 10.1186/s13054-023-04701-5.
PubMed 37932787Bollaert PE, Monnier A, Schneider F, Argaud L, Badie J, Charpentier C, Meziani F, Bemer M, Quenot JP, Buzzi M, Outin H, Bruel C, Ziegler L, Gibot S, Virion JM, Alleyrat C, Louis G, Agrinier N. Fluid balance control in critically ill patients: results from POINCARE-2 stepped wedge cluster-randomized trial. Crit Care. 2023 Feb 21;27(1):66. doi: 10.1186/s13054-023-04357-1.
PubMed 36810101
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study
- ClinicalTrials.gov ID
- NCT02765009
- Acronym / sponsor ID
- POINCARE / 2015-A00662-47
- Conditions
- Fluid Shifts, Critical Care
- Keywords
- Fluid overload, Multiple organ failure, Diuretics, Fluid restriction, Body weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,411 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 6 May 2016 (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.
Most ICU patients develop a positive fluid balance, mainly during the two first weeks of their stay. The causes are multifactorial: a reduced urine output subsequent to shock state, positive pressure mechanical ventilation, acute renal failure, post-operative period of major surgical procedures, and simultaneous fluid loading to maintain volemia and acceptable arterial pressure. Additionally, the efficacy of fluid loading is frequently suboptimal, in relation to severe hypoalbuminemia and inflammatory capillary leakage. This results usually in a cumulated positive fluid balance of more than 10 litres at the end of the first week of stay. A high number of studies have showed that such a positive fluid balance was an independent factor of worse prognosis in selected populations of ICU patients: acute renal failure, acute respiratory distress syndrome (ARDS), sepsis, post-operative of high risk surgery. However, little is known about the putative causal role of positive fluid balance by itself on outcome. However, in two randomized controlled studies in patients with ARDS, a strategy of fluid balance control has been demonstrated to reduce time under mechanical ventilation and ICU length of stay with no noticeable adverse effects. Although avoiding fluid overload is now recommended in ARDS management, there is no evidence that this approach would be beneficial in a more general population of ICU patients (i.e. with sepsis, acute renal failure, mechanical ventilation). In addition, fluid restriction -mainly if applied early could be deleterious in reducing both tissue oxygen delivery and perfusion pressure. There is a place for a prospective study comparing a "conventional" attitude based on liberal fluid management throughout the ICU stay with a restrictive approach aiming at controlling fluid balance, at least as soon as the patient circulatory status is stabilized. The latter approach would use a simple algorithm using fluid restriction and diuretics based on daily weighing, a common procedure in the ICU, probably more reliable than cumulative measurement of fluid movements in patients whose limits have been underlined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care provided according to the ward policy. Patients have to be weighed at least on admission (day 0), day 7 and day 14. |
| Strategy | Experimental | Drug: diuretics, Drug: albumin, Other: fluid restriction, Device: renal replacementPatients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients under mechanical ventilation, admitted for > 48h and <72h and no discharge planned for the next 24h
Key exclusion criteria (7 listed)
- Age < 18 years
- Failure to weigh the patient
- Multiple trauma
- Transfer from another ICU with a previous stay > 24h
- High probability of withdrawing treatment for ethical purposes within 7 days
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 |
|---|---|---|
| diureticsAlso: hydrochlorothiazide, bumetanide, furosemideUsed to reduce fluid overload as evidenced by weight gain | Drug | Strategy |
| albuminUsed to reduce fluid overload in addition with diuretics in hypoalbuminemic patients | Drug | Strategy |
| fluid restrictionUsed to reduce fluid overload | Other | Strategy |
| renal replacementAlso: ultrafiltrationUsed to reduce fluid overload in patients with renal replacement | Device | Strategy |
Primary outcome
All-cause mortality at 60 days after inclusion
Time frame: 60 days
Vital status collected 60 days after admission; if the patient was dead at the time of assessment, date of death was collected
12 secondary outcomes
Fluid balance control at day 7
Time frame: 7 days
Fluid balance control at day 14
Time frame: 14 days
All-cause mortality at 28-day after inclusion
Time frame: 28 days
All-cause in-hospital mortality
Time frame: Up to 24 weeks
All-cause mortality at 365 days after inclusion
Time frame: 365 days
Survival time period at Day 60
Time frame: 60 days
Survival time period at Day 365
Time frame: 365 days
Global end-organ damage assessment
Time frame: 28 days
Dependence on vasopressor drugs
Time frame: 28 days
Dependence on mechanical ventilation
Time frame: 28 days
Dependence on renal replacement therapy
Time frame: 60 days
Cumulated number of pre-defined adverse events
Time frame: 14 days
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 22 Sep 2020.
- Background: PubMed 31260794Agrinier N, Monnier A, Argaud L, Bemer M, Virion JM, Alleyrat C, Charpentier C, Ziegler L, Louis G, Bruel C, Jamme M, Quenot JP, Badie J, Schneider F, Bollaert PE. Effect of fluid balance control in critically ill patients: Design of the stepped wedge trial POINCARE-2. Contemp Clin Trials. 2019 Aug;83:109-116. doi: 10.1016/j.cct.2019.06.020. Epub 2019 Jun 29.
- Derived from this study: PubMed 39048932Buzzi M, Ricci L, Gibot S, Argaud L, Badie J, Bruel C, Charpentier C, Outin H, Louis G, Monnier A, Quenot JP, Schneider F, Minary L, Agrinier N. Implementation of a fluid balance control strategy in critically ill patients: POINCARE-2 trial process evaluation. BMC Med Res Methodol. 2024 Jul 24;24(1):160. doi: 10.1186/s12874-024-02288-1.
- Derived from this study: PubMed 37932787Mansouri A, Buzzi M, Gibot S, Charpentier C, Schneider F, Louis G, Outin H, Monnier A, Quenot JP, Badie J, Argaud L, Bruel C, Soudant M, Agrinier N; the POINCARE-2 group. Fluid balance control in critically ill patients: results from as-treated analyses of POINCARE-2 randomized trial. Crit Care. 2023 Nov 6;27(1):426. doi: 10.1186/s13054-023-04701-5.
- Derived from this study: PubMed 36810101Bollaert PE, Monnier A, Schneider F, Argaud L, Badie J, Charpentier C, Meziani F, Bemer M, Quenot JP, Buzzi M, Outin H, Bruel C, Ziegler L, Gibot S, Virion JM, Alleyrat C, Louis G, Agrinier N. Fluid balance control in critically ill patients: results from POINCARE-2 stepped wedge cluster-randomized trial. Crit Care. 2023 Feb 21;27(1):66. doi: 10.1186/s13054-023-04357-1.
- Individual participant dataSharing planned: No
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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.
El Mehdi Siaghy study director
Central Hospital, Nancy, France
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diuretics, albumin and fluid restriction in people with Fluid Shifts and Critical Care, run by Central Hospital, Nancy, France at 11 sites in France.
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 7 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 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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?
All-cause mortality at 60 days after inclusion (time frame: 60 days). 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 NCT02765009, which also lists 4 linked publications.
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 22 Sep 2020.