POINCARE: Effects of Fluid Balance Control in Critically Ill Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Usual care provided according to the ward policy. Patients have to be weighed at least on admission (day 0), day 7 and day 14. |
|
| Experimental: Strategy 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) |
Drug: diuretics
Used to reduce fluid overload as evidenced by weight gain
Other Names:
Drug: albumin
Used to reduce fluid overload in addition with diuretics in hypoalbuminemic patients
Other: fluid restriction
Used to reduce fluid overload
Device: renal replacement
Used to reduce fluid overload in patients with renal replacement
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients under mechanical ventilation, admitted for > 48h and <72h and no discharge planned for the next 24h
Exclusion Criteria:
-
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
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Pregnancy
-
Patient refusal
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hopital Nord Franche-Comté | Belfort | France | 90000 | |
| 2 | Centre Hospitalier Universitaire | Dijon | France | 21000 | |
| 3 | Centre Hospitalier Universitaire | Lyon | France | 69000 | |
| 4 | Centre Hospitalier Régional | Metz | France | 57000 | |
| 5 | Centre Hospitalier Régional et Universitaire | Nancy | France | 54000 | |
| 6 | Groupe Hospitalier Saint Joseph | Paris | France | 75000 | |
| 7 | Centre Hospitalier intercommunal | Poissy | France | 78303 | |
| 8 | Centre Hospitalier Régional et Universitaire | Strasbourg | France | 67000 | |
| 9 | CentreHospitalier Régional et universitaire | Strasbourg | France | 67000 | |
| 10 | Centre Hospitalier Régional | Thionville | France | 57000 | |
| 11 | Centre Hospitalier | Verdun | France | 55100 |
Sponsors and Collaborators
- Central Hospital, Nancy, France
- Ministry of Health, France
Investigators
- Study Director: El Mehdi Siaghy, Central Hospital, Nancy, France
Study Documents (Full-Text)
None provided.More Information
Publications
- 2015-A00662-47