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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diuretics | Drug | Used to reduce fluid overload as evidenced by weight gain |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid balance control at day 7 | Mean differences of patient body weight between Day 7 and admission (Day 0) | 7 days |
| Fluid balance control at day 14 | Mean differences of patient body weight between Day 14 and admission (Day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| El Mehdi Siaghy | Central Hospital, Nancy, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Nord Franche-Comté | Belfort | 90000 | France | |||
| Centre Hospitalier Universitaire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31260794 | Background | 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. | |
| 39048932 |
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| ID | Term |
|---|---|
| D004487 | Edema |
| D009102 | Multiple Organ Failure |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004232 | Diuretics |
| D006852 | Hydrochlorothiazide |
| D002034 | Bumetanide |
| D005665 | Furosemide |
| D000418 | Albumins |
| D014462 | Ultrafiltration |
| ID | Term |
|---|---|
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| albumin | Drug | Used to reduce fluid overload in addition with diuretics in hypoalbuminemic patients |
|
| fluid restriction | Other | Used to reduce fluid overload |
|
| renal replacement | Device | Used to reduce fluid overload in patients with renal replacement |
|
|
| 14 days |
| All-cause mortality at 28-day after inclusion | Vital status collected 28 days after admission | 28 days |
| All-cause in-hospital mortality | Death during the hospital stay where the patient was included in the study | Up to 24 weeks |
| All-cause mortality at 365 days after inclusion | Vital status collected one year after admission | 365 days |
| Survival time period at Day 60 | Time-related mortality, calculated from admission to the date of death | 60 days |
| Survival time period at Day 365 | Time-related mortality, calculated from admission to the date of death | 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. | 28 days |
| Dependence on vasopressor drugs | Cumulated number of vasopressor-free days alive from day 0 to day 28 | 28 days |
| Dependence on mechanical ventilation | Cumulated number of ventilator-free days alive from day 0 to day 28 | 28 days |
| Dependence on renal replacement therapy | Cumulated number of renal replacement-free days alive from day 0 to day 60 | 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) | 14 days |
| Dijon |
| 21000 |
| France |
| Centre Hospitalier Universitaire | Lyon | 69000 | France |
| Centre Hospitalier Régional | Metz | 57000 | France |
| Centre Hospitalier Régional et Universitaire | Nancy | 54000 | France |
| Groupe Hospitalier Saint Joseph | Paris | 75000 | France |
| Centre Hospitalier intercommunal | Poissy | 78303 | France |
| Centre Hospitalier Régional et Universitaire | Strasbourg | 67000 | France |
| CentreHospitalier Régional et universitaire | Strasbourg | 67000 | France |
| Centre Hospitalier Régional | Thionville | 57000 | France |
| Centre Hospitalier | Verdun | 55100 | France |
| Buzzi 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. |
| 37932787 | Derived | Mansouri 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. |
| 36810101 | Derived | Bollaert 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. |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000577 | Amides |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D005374 | Filtration |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055585 | Physical Phenomena |
| D055598 | Chemical Phenomena |