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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,411
Used to reduce fluid overload as evidenced by weight gain
Used to reduce fluid overload in addition with diuretics in hypoalbuminemic patients
Used to reduce fluid overload
Used to reduce fluid overload in patients with renal replacement
Hopital Nord Franche-Comté
Belfort, France
Centre Hospitalier Universitaire
Dijon, France
Centre Hospitalier Universitaire
Lyon, France
Centre Hospitalier Régional
Metz, France
Centre Hospitalier Régional et Universitaire
Nancy, France
Groupe Hospitalier Saint Joseph
Paris, France
Centre Hospitalier intercommunal
Poissy, France
Centre Hospitalier Régional et Universitaire
Strasbourg, France
CentreHospitalier Régional et universitaire
Strasbourg, France
Centre Hospitalier Régional
Thionville, France
...and 1 more locations
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
Time frame: 60 days
Fluid balance control at day 7
Mean differences of patient body weight between Day 7 and admission (Day 0)
Time frame: 7 days
Fluid balance control at day 14
Mean differences of patient body weight between Day 14 and admission (Day 0)
Time frame: 14 days
All-cause mortality at 28-day after inclusion
Vital status collected 28 days after admission
Time frame: 28 days
All-cause in-hospital mortality
Death during the hospital stay where the patient was included in the study
Time frame: Up to 24 weeks
All-cause mortality at 365 days after inclusion
Vital status collected one year after admission
Time frame: 365 days
Survival time period at Day 60
Time-related mortality, calculated from admission to the date of death
Time frame: 60 days
Survival time period at Day 365
Time-related mortality, calculated from admission to the date of death
Time frame: 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.
Time frame: 28 days
Dependence on vasopressor drugs
Cumulated number of vasopressor-free days alive from day 0 to day 28
Time frame: 28 days
Dependence on mechanical ventilation
Cumulated number of ventilator-free days alive from day 0 to day 28
Time frame: 28 days
Dependence on renal replacement therapy
Cumulated number of renal replacement-free days alive from day 0 to day 60
Time frame: 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)
Time frame: 14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.