Effects of Fluid Balance Control in Critically Ill Patients
- Conditions
- Fluid ShiftsCritical Care
- Interventions
- Registration Number
- NCT02765009
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1411
- Patients under mechanical ventilation, admitted for > 48h and <72h and no discharge planned for the next 24h
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Strategy albumin 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) Strategy fluid restriction 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) Strategy diuretics 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) Strategy renal replacement 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)
- Primary Outcome Measures
Name Time Method All-cause mortality at 60 days after inclusion 60 days Vital status collected 60 days after admission; if the patient was dead at the time of assessment, date of death was collected
- Secondary Outcome Measures
Name Time Method Fluid balance control at day 7 7 days Mean differences of patient body weight between Day 7 and admission (Day 0)
Fluid balance control at day 14 14 days Mean differences of patient body weight between Day 14 and admission (Day 0)
All-cause mortality at 28-day after inclusion 28 days Vital status collected 28 days after admission
All-cause in-hospital mortality Up to 24 weeks Death during the hospital stay where the patient was included in the study
All-cause mortality at 365 days after inclusion 365 days Vital status collected one year after admission
Survival time period at Day 60 60 days Time-related mortality, calculated from admission to the date of death
Survival time period at Day 365 365 days Time-related mortality, calculated from admission to the date of death
Global end-organ damage assessment 28 days 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.
Dependence on vasopressor drugs 28 days Cumulated number of vasopressor-free days alive from day 0 to day 28
Dependence on mechanical ventilation 28 days Cumulated number of ventilator-free days alive from day 0 to day 28
Dependence on renal replacement therapy 60 days Cumulated number of renal replacement-free days alive from day 0 to day 60
Cumulated number of pre-defined adverse events 14 days 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)
Trial Locations
- Locations (8)
Centre Hospitalier Régional
🇫🇷Thionville, France
Centre Hospitalier Régional et Universitaire
🇫🇷Strasbourg, France
Hopital Nord Franche-Comté
🇫🇷Belfort, France
Centre Hospitalier intercommunal
🇫🇷Poissy, France
Groupe Hospitalier Saint Joseph
🇫🇷Paris, France
CentreHospitalier Régional et universitaire
🇫🇷Strasbourg, France
Centre Hospitalier
🇫🇷Verdun, France
Centre Hospitalier Universitaire
🇫🇷Lyon, France