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Completed

NCT Number: NCT02765009

Effects of Fluid Balance Control in Critically Ill Patients

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Nord Franche-Comté, Belfort, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diuretics

Drug

Used to reduce fluid overload as evidenced by weight gain

Other names: hydrochlorothiazide, bumetanide, furosemide

ALBUMIN

Drug

Used to reduce fluid overload in addition with diuretics in hypoalbuminemic patients

fluid restriction

Other

Used to reduce fluid overload

renal replacement

Device

Used to reduce fluid overload in patients with renal replacement

Other names: ultrafiltration

Primary outcomes

  1. All-cause mortality at 60 days after inclusion

    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

Secondary outcomes

  1. Fluid balance control at day 7

    Time frame: 7 days

    Mean differences of patient body weight between Day 7 and admission (Day 0)

  2. Fluid balance control at day 14

    Time frame: 14 days

    Mean differences of patient body weight between Day 14 and admission (Day 0)

  3. All-cause mortality at 28-day after inclusion

    Time frame: 28 days

    Vital status collected 28 days after admission

  4. All-cause in-hospital mortality

    Time frame: Up to 24 weeks

    Death during the hospital stay where the patient was included in the study

  5. All-cause mortality at 365 days after inclusion

    Time frame: 365 days

    Vital status collected one year after admission

  6. Survival time period at Day 60

    Time frame: 60 days

    Time-related mortality, calculated from admission to the date of death

  7. Survival time period at Day 365

    Time frame: 365 days

    Time-related mortality, calculated from admission to the date of death

  8. Global end-organ damage assessment

    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.

  9. Dependence on vasopressor drugs

    Time frame: 28 days

    Cumulated number of vasopressor-free days alive from day 0 to day 28

  10. Dependence on mechanical ventilation

    Time frame: 28 days

    Cumulated number of ventilator-free days alive from day 0 to day 28

  11. Dependence on renal replacement therapy

    Time frame: 60 days

    Cumulated number of renal replacement-free days alive from day 0 to day 60

  12. Cumulated number of pre-defined adverse events

    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)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: POINCARE

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
May 6, 2016
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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