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Effects of Fluid Balance Control in Critically Ill Patients (POINCARE)

21. september 2020 oppdatert av: Central Hospital, Nancy, France

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

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1411

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Belfort, Frankrike, 90000
        • Hopital Nord Franche-Comté
      • Dijon, Frankrike, 21000
        • Centre Hospitalier Universitaire
      • Lyon, Frankrike, 69000
        • Centre Hospitalier Universitaire
      • Metz, Frankrike, 57000
        • Centre Hospitalier Regional
      • Nancy, Frankrike, 54000
        • Centre Hospitalier Regional Et Universitaire
      • Paris, Frankrike, 75000
        • Groupe Hospitalier Saint Joseph
      • Poissy, Frankrike, 78303
        • Centre Hospitalier Intercommunal
      • Strasbourg, Frankrike, 67000
        • Centre Hospitalier Regional Et Universitaire
      • Strasbourg, Frankrike, 67000
        • CentreHospitalier Régional et universitaire
      • Thionville, Frankrike, 57000
        • Centre Hospitalier Regional
      • Verdun, Frankrike, 55100
        • Centre Hospitalier

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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.
Eksperimentell: 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)
Legemiddel: diuretics
Used to reduce fluid overload as evidenced by weight gain
Andre navn:
  • furosemid
  • hydroklortiazid
  • bumetanid
Legemiddel: albumin
Used to reduce fluid overload in addition with diuretics in hypoalbuminemic patients
Annen: fluid restriction
Used to reduce fluid overload
Enhet: renal replacement
Used to reduce fluid overload in patients with renal replacement
Andre navn:
  • ultrafiltrering

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-cause mortality at 60 days after inclusion
Tidsramme: 60 days
Vital status collected 60 days after admission; if the patient was dead at the time of assessment, date of death was collected
60 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fluid balance control at day 7
Tidsramme: 7 days
Mean differences of patient body weight between Day 7 and admission (Day 0)
7 days
Fluid balance control at day 14
Tidsramme: 14 days
Mean differences of patient body weight between Day 14 and admission (Day 0)
14 days
All-cause mortality at 28-day after inclusion
Tidsramme: 28 days
Vital status collected 28 days after admission
28 days
All-cause in-hospital mortality
Tidsramme: Up to 24 weeks
Death during the hospital stay where the patient was included in the study
Up to 24 weeks
All-cause mortality at 365 days after inclusion
Tidsramme: 365 days
Vital status collected one year after admission
365 days
Survival time period at Day 60
Tidsramme: 60 days
Time-related mortality, calculated from admission to the date of death
60 days
Survival time period at Day 365
Tidsramme: 365 days
Time-related mortality, calculated from admission to the date of death
365 days
Global end-organ damage assessment
Tidsramme: 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.
28 days
Dependence on vasopressor drugs
Tidsramme: 28 days
Cumulated number of vasopressor-free days alive from day 0 to day 28
28 days
Dependence on mechanical ventilation
Tidsramme: 28 days
Cumulated number of ventilator-free days alive from day 0 to day 28
28 days
Dependence on renal replacement therapy
Tidsramme: 60 days
Cumulated number of renal replacement-free days alive from day 0 to day 60
60 days
Cumulated number of pre-defined adverse events
Tidsramme: 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)
14 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Central Hospital, Nancy, France

Samarbeidspartnere

Ministry of Health, France

Etterforskere

  • Studieleder: El Mehdi SIAGHY, Central Hospital, Nancy, France

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2016

Primær fullføring (Faktiske)

31. juli 2019

Studiet fullført (Faktiske)

25. mai 2020

Datoer for studieregistrering

Først innsendt

29. april 2016

Først innsendt som oppfylte QC-kriteriene

5. mai 2016

Først lagt ut (Anslag)

6. mai 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. september 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. september 2020

Sist bekreftet

1. september 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2015-A00662-47

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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