Diuretics
DrugUsed to reduce fluid overload as evidenced by weight gain
Other names: hydrochlorothiazide, bumetanide, furosemide
NCT Number: NCT02765009
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hopital Nord Franche-Comté, Belfort, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Used to reduce fluid overload as evidenced by weight gain
Other names: hydrochlorothiazide, bumetanide, furosemide
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
Other names: ultrafiltration
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
Time frame: 7 days
Mean differences of patient body weight between Day 7 and admission (Day 0)
Time frame: 14 days
Mean differences of patient body weight between Day 14 and admission (Day 0)
Time frame: 28 days
Vital status collected 28 days after admission
Time frame: Up to 24 weeks
Death during the hospital stay where the patient was included in the study
Time frame: 365 days
Vital status collected one year after admission
Time frame: 60 days
Time-related mortality, calculated from admission to the date of death
Time frame: 365 days
Time-related mortality, calculated from admission to the date of death
Time frame: 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.
Time frame: 28 days
Cumulated number of vasopressor-free days alive from day 0 to day 28
Time frame: 28 days
Cumulated number of ventilator-free days alive from day 0 to day 28
Time frame: 60 days
Cumulated number of renal replacement-free days alive from day 0 to day 60
Time frame: 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)
Central Hospital, Nancy, France
Other
Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study
Acronym: POINCARE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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