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

21. september 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1411

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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)
Medicin: diuretics
Used to reduce fluid overload as evidenced by weight gain
Andre navne:
  • furosemid
  • hydrochlorthiazid
  • bumetanid
Medicin: albumin
Used to reduce fluid overload in addition with diuretics in hypoalbuminemic patients
Andet: fluid restriction
Used to reduce fluid overload
Enhed: renal replacement
Used to reduce fluid overload in patients with renal replacement
Andre navne:
  • ultrafiltrering

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Central Hospital, Nancy, France

Samarbejdspartnere

Ministry of Health, France

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2016

Primær færdiggørelse (Faktiske)

31. juli 2019

Studieafslutning (Faktiske)

25. maj 2020

Datoer for studieregistrering

Først indsendt

29. april 2016

Først indsendt, der opfyldte QC-kriterier

5. maj 2016

Først opslået (Skøn)

6. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. september 2020

Sidst verificeret

1. september 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2015-A00662-47

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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