Effects of Fluid Balance Control in Critically Ill Patients

Critical Care Clinical Trial

— POINCARE  

Official title:

Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765009
• Other study ID #: 2015-A00662-47
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: May 25, 2020

Study information

• Verified date: September 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1411
• Est. completion date: May 25, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Pregnancy

• Patient refusal

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Fluid Shifts

Intervention

Drug:
• diuretics
Used to reduce fluid overload as evidenced by weight gain
• 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

Locations

Country	Name	City	State
France	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	Centre Hospitalier	Verdun

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Fluid balance control at day 7	Mean differences of patient body weight between Day 7 and admission (Day 0)	7 days
Secondary	Fluid balance control at day 14	Mean differences of patient body weight between Day 14 and admission (Day 0)	14 days
Secondary	All-cause mortality at 28-day after inclusion	Vital status collected 28 days after admission	28 days
Secondary	All-cause in-hospital mortality	Death during the hospital stay where the patient was included in the study	Up to 24 weeks
Secondary	All-cause mortality at 365 days after inclusion	Vital status collected one year after admission	365 days
Secondary	Survival time period at Day 60	Time-related mortality, calculated from admission to the date of death	60 days
Secondary	Survival time period at Day 365	Time-related mortality, calculated from admission to the date of death	365 days
Secondary	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
Secondary	Dependence on vasopressor drugs	Cumulated number of vasopressor-free days alive from day 0 to day 28	28 days
Secondary	Dependence on mechanical ventilation	Cumulated number of ventilator-free days alive from day 0 to day 28	28 days
Secondary	Dependence on renal replacement therapy	Cumulated number of renal replacement-free days alive from day 0 to day 60	60 days
Secondary	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