Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Canadian Critical Care Comparative Effectiveness Platform (CEPEC)

2. november 2026 oppdatert av: Université de Sherbrooke

Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en Soins Critiques (CEPEC)

The Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en soins Critiques (CEPEC) is an international multi-centered randomized adaptive platform clinical trial. CEPEC will evaluate supportive care interventions that are used routinely in intensive care units throughout the world.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Many supportive therapies used daily in the ICU setting remain under-studied despite being resource-intensive. CEPEC aims to incorporate domains evaluating vasopressors and inotropes, nutrition, transfusions, sedation, correction of electrolyte deficits, sedation and analgesia, airway management, end-of-life care practices and other interventions.

Domains refer to categories of patient care for which interventions are being evaluated in a randomized controlled trial (RCT) within the platform.

VASOPRESSOR DOMAIN The investigators will investigate whether vasoactive medications should be used differently for different subgroups of patients who are in a state of cardiovascular shock (i.e. heterogeneity of treatment effects). Vasoactive medications are common in critically ill patients, and have considerable patient, hospital, and health system resource impact, but their use remains poorly supported by scientific evidence.

PLATELET DOMAIN Platelet transfusions are commonly prescribed to critically ill patients and have considerable patient, hospital, and health system resource impact, but remain poorly supported by scientific evidence. We propose to join a multicentre randomized clinical trial (T4P, ISRCTN79371664) addressing the optimal use of platelet transfusions for critically ill patients with thrombocytopenia in advance of invasive procedures. A multinational collaboration will ensure timely completion of this high-impact multicentre randomized clinical trial. The Canadian component of the T4P trial is embedded in the CEPEC platform as the Platelet Domain.

NUTRITION DOMAIN Most critically ill patients cannot eat normally and require a specialized method of feeding, called enteral nutrition. It is provided every hour around the clock. This differs from how we usually eat, with meals (boluses) divided over the day while we are awake. The goals of this study are to determine if a large study can be successfully done comparing nutrition given 3 times a day (boluses) compared to given in small amounts every hour (continuously).

INITIATIVES Initiatives are cross-cutting non-randomized studies nested within the platform that are relevant to all domains. Examples include a parallel observational study initiative, which aims to collect data about usual care and outcomes directly relevant to each domain. The goal is to describe the representativeness of domain results and to assess for protocol misalignment. Similarly, the living knowledge synthesis and health economics initiatives aim to generate meta-analyses and cost-effectiveness analyses alongside each trial conducted in the platform.

Studietype

Intervensjonell

Registrering (Antatt)

5500

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 2Z3
        • Rekruttering
        • Centre hospitalier universitaire Dr-Georges-L.-Dumont
        • Ta kontakt med:
        • Hovedetterforsker:
          • Rémi Leblanc
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Rekruttering
        • Hamilton General Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kimia Honarmand
      • Hamilton, Ontario, Canada, L8V 1C3
        • Rekruttering
        • Hamilton Health Sciences - Juravinski Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bram Rochwerg
      • Ottawa, Ontario, Canada, K1H 8L6
        • Rekruttering
        • The Ottawa Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alexandre Tran
      • Scarborough Village, Ontario, Canada, M1P 2V5
        • Rekruttering
        • Scarborough Health Network
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher Yarnell
      • St. Catharines, Ontario, Canada, L2S 0A9
        • Rekruttering
        • Niagara Health
        • Hovedetterforsker:
          • Jennifer Tsang
        • Ta kontakt med:
      • Toronto, Ontario, Canada, M4N 3M5
        • Rekruttering
        • Sunnybrook Health Sciences Centre
        • Ta kontakt med:
        • Hovedetterforsker:
          • Neill Adhikari
    • Quebec
      • Longueuil, Quebec, Canada, J4V 2H1
        • Rekruttering
        • Hôpital Charles-Le Moyne
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dany Burke
      • Montreal, Quebec, Canada, H2X 0C1
        • Rekruttering
        • Centre hospitalier de l'Université de Montréal (CHUM)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Francois-Martin Carrier
      • Montreal, Quebec, Canada, H4J 1C5
        • Rekruttering
        • CIUSSS NIM - Hôpital du Sacré-Coeur-de-Montréal
        • Ta kontakt med:
        • Hovedetterforsker:
          • Yiorgos Alexandros Cavayas
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Rekruttering
        • CIUSSS de l'Estrie - CHUS
        • Ta kontakt med:
        • Hovedetterforsker:
          • Francois Lamontagne
        • Ta kontakt med:
  • New Zealand
      • Auckland, New Zealand
        • Har ikke rekruttert ennå
        • Auckland City Hospital
  • Storbritannia
      • London, Storbritannia
        • Har ikke rekruttert ennå
        • Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Sites to be determined)

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

VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor Domain.

Inclusion criteria:

  1. Ongoing vasopressor infusion to treat hypotension, or would be used to treat clinician-defined hypotension as part of usual care;
  2. MAP <75 mmHg at any point;
  3. Patient expected to be in the ICU for >24 hours.

Exclusion criteria:

  1. Treating team does not have equipoise for at least two contiguous MAP target ranges in the CEPEC Vasopressor Domain;
  2. Acute traumatic brain injury (within 7 days or ongoing active treatment for elevated intracranial pressure);
  3. Acute subarachnoid hemorrhage (within 21 days);
  4. Acute spinal cord injury (within 7 days of injury or ongoing vasopressor therapy for suspected spinal cord ischemia);
  5. Lung, heart, liver, kidney transplant recipient (within 7 days);
  6. Patient expected to become an organ donor (Donor Neurologic Death - DND or Donation After Circulatory Death - DCD);
  7. More than 24 hours since meeting inclusion criteria in the ICU;
  8. Previously randomized into the CEPEC Vasopressor Domain or a confounding trial.

PLATELET DOMAIN

Inclusion criteria:

  1. Adult patients (age ≥18 years) admitted to the ICU;
  2. Latest platelet count in this hospital admission <50×109/L;
  3. Planned to undergo a specified low-moderate bleeding risk invasive procedure.

Exclusion criteria:

  1. Ongoing major hemorrhage requiring blood products and/or surgical/ radiological intervention;
  2. Intracranial hemorrhage within prior 72 hours;
  3. Contraindications to platelet transfusion (e.g. thrombotic microangiopathies, heparin-induced thrombocytopenia, recent history of immune thrombocytopaenia, congenital platelet function defects);
  4. Known advance decision of refusing blood/blood component transfusions;
  5. Acute promyelocytic leukemia (APML);
  6. Death perceived as imminent or admission for palliation;
  7. Previously randomized into the CEPEC Platelet Domain or the T4P Trial;
  8. Fulfilled all the inclusion criteria and none of the exclusion criteria ≥72 hours.

NUTRITION DOMAIN

Inclusion criteria:

  1. Patient of ≥18 years of age;
  2. Patient is invasively mechanically ventilated (including endotracheal tube or tracheostomy);
  3. Orogastric/nasogastric tube in place; or have an in dwelling percutaneous gastric tube (with confirmed placement);
  4. Treating team has started or has the intention of providing enteral nutrition.

Exclusion criteria:

  1. Patient who has had gastrointestinal (GI) surgery in the last 3 months and deemed not ready to receive possible bolus nutrition;
  2. Bowel obstruction or ischemia; active;
  3. Has a post-pyloric small bowel feeding tube;
  4. Active GI bleeding;
  5. Patient who is chronically receiving enteral nutrition.

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: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Vasopressor

Participants will receive vasopressor(s) and their mean arterial pressure will be titrated according to the group they are randomized to (group 1: 56-60 mmHg; group 2: 61-65 mmHg; group 3: 66-70 mmHg; group 4: 71-75 mmHg). Physicians will have the liberty of restricting the randomization to at least 2 contiguous ranges.
Legemiddel: 1- Vasopressor - Mean arterial pressure 56-60

Vasopressor(s) will be titrated according to 56-60 range.

Legemiddel: 2- Vasopressor - Mean arterial pressure 61-65

Vasopressor(s) will be titrated according to 61-65 range.

Legemiddel: 3- Vasopressor - Mean arterial pressure 66-70

Vasopressor(s) will be titrated according to 66-70 range.

Legemiddel: 4- Vasopressor - Mean arterial pressure 71-75

Vasopressor(s) will be titrated according to 71-75 range.
Annen: Platelet

Thrombocytopenic intensive care unit (ICU) patients (platelet count <50×109/L) with a planned low-moderate bleeding-risk procedure will be randomized to one of five equally spaced platelet thresholds (less than 10 x 109/L, less than 20 x 109/L, less than 30 x 109/L, less than 40 x 109/L, less than 50 X 109/L) below which they will receive prophylactic platelet transfusions before any low-moderate bleeding-risk procedure occurring during the ICU episode up to ICU day 90. Once randomized, the clinical team will administer a platelet transfusion according to the assigned threshold and the most recent platelet count at the time of the planned procedure.
Annen: 1- Platelet less than 10 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 10 x 109/L at the time of the planned procedure.

Annen: 2- Platelet less than 20 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 20 x 109/L at the time of the planned procedure.

Annen: 3- Platelet less than 30 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 30 x 109/L at the time of the planned procedure.

Annen: 4- Platelet less than 40 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 40 x 109/L at the time of the planned procedure.

Annen: 5- Platelet less than 50 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 50 x 109/L at the time of the planned procedure.
Annen: Nutrition

The intervention is bolus feeding (given 3 times a day to meet nutritional targets) with formula type left to the discretion of the precribing team. With 2 hours between each "feed".

The control is continuous feeding (over 24-hour period) with formula type left to the discretion of the prescribing team, which is the current standard of care.
Annen: Enteral nutrition - Boluses

Given 3 times a day.

Annen: Enteral nutrition - Continuous

Given over 24-hour period

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Platelet Domain - All cause mortality
Tidsramme: 90 days

90-day all-cause mortality
90 days
Nutrition Domain - Recruitment rate
Tidsramme: 1 year

Recruitment rate of 2 patients per site per month.
1 year
Vasopressor Domain - 30-day ordinal outcome
Tidsramme: At hospital discharge up to day 30

Incorporate mortality, persistent organ dysfunction (POD) in the ICU, hospitalization, discharge to a location providing more health services than at the patient's baseline residence, and discharge to baseline level residence.
At hospital discharge up to day 30

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blodplatedomenet - Dødelighet ved utskrivning fra sykehus
Tidsramme: Utslipp fra sykehus
Utslipp fra sykehus
Blodplatedomenet - dødelighet etter 1 år
Tidsramme: 1 år etter randomisering
1 år etter randomisering
Blodplatedomenet - Blødende utfall på sykehus (Major and Fatal Blays)
Tidsramme: Under sykehusinnleggelse
Under sykehusinnleggelse
Blodplatedomenet - dager i live og hjemme på dag 90
Tidsramme: 90 dager
90 dager
Platelet Domain - Transfusion complications
Tidsramme: During hospitalization

Transfusion-associated circulatory overload, transfusion-related acute lung injury, infections, anaphylaxis
During hospitalization
Platelet Domain - Health-related quality of life
Tidsramme: 90 days

Evaluated using EQ-5D-5L questionnaire
90 days
Nutrition Domain - Diarrhea
Tidsramme: 24 hours

Defined by the World Health Organization (WHO) definition (3 or greater liquids stools/24 hours)
24 hours
Nutition Domain - Percentage of target nutritional intake
Tidsramme: Over the course of the ICU stay up to day 30

>80%
Over the course of the ICU stay up to day 30
Nutrition Domain - Vomiting
Tidsramme: During ICU stay up to day 30

Vomiting 2 or more times in a 24-hour period
During ICU stay up to day 30
Vasopressor, Platelet and Nutrition Domains - Each component of the 30-day ordinal primary outcome
Tidsramme: At hospital discharge up to day 30
  1. Mortality
  2. POD in the ICU
  3. Hospitalization
  4. Discharge to a location providing more health services than at the patient's baseline residence
  5. Discharge to baseline level residence.
At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Days free of POD to day 30
Tidsramme: At hospital discharge up to day 30

POD is defined as a vasopressor infusion, invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen (delivered via nasal prongs or cannula by a specialized device, with a FiO2 ≥0.4 and at a flow rate ≥30L/min), or new renal replacement therapy.
At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Hospital days up to day 30
Tidsramme: Up to day 30
Up to day 30
Vasopressor, Platelet and Nutrition Domains - ICU days to day 30
Tidsramme: Up to day 30
Up to day 30
Platelet Domain - Number of days without POD in the ICU
Tidsramme: Up to day 90
Up to day 90

Samarbeidspartnere og etterforskere

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

Sponsor

Université de Sherbrooke

Samarbeidspartnere

Hamilton Health Sciences Corporation

Etterforskere

  • Hovedetterforsker: Francois Lamontagne, MD, MSc, Université de Sherbrooke
  • Hovedetterforsker: Neill Adhikari, MDCM, MSc, Sunnybrook Research Institute

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.

Hjelpsomme linker

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)

23. mars 2025

Primær fullføring (Antatt)

31. desember 2029

Studiet fullført (Antatt)

30. juni 2030

Datoer for studieregistrering

Først innsendt

10. september 2024

Først innsendt som oppfylte QC-kriteriene

17. september 2024

Først lagt ut (Faktiske)

20. september 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • MP-31-2025-5600

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere