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Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients (RESCUEII)

26. juni 2012 opdateret af: PHJ van der Voort, Onze Lieve Vrouwe Gasthuis

Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients; a Randomized Controlled Trial (RESCUEII)

The purpose of this study is to evaluate the accuracy and reliability of the continuous glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill patients by comparing subcutaneous measuring with the current standard of arterial measuring by a point of care glucometer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Most patients admitted to the ICU are treated with intensive insulin therapy, according to a locally developed glucose treatment protocol. The use of a continuous glucose monitoring in critically ill patients could have the following advantages:

  • Better insight in the alterations of the blood glucose levels
  • Early detection of hypoglycemia's or hyperglycaemia's, and subsequently more stable glycemic levels.
  • Fewer blood samples
  • Decreased workload for the nursing staff

In this study, patients will be randomized in: 1. The Freestyle group or 2. The AccuChek Group.

Patients in both groups will receive a Freestyle Navigator device, which will stay on the patient up to 5 days, or until discharge from the ICU.

The medical treatment of both study groups will be equal, except for the frequency of the glucose level measurements and the resulting adjustments according to the treatment protocol. In the Freestyle group extra glucose level measurements will be made in response to alarms from the device.

In both groups, every 4 hours blood glucose values will be obtained using a blood gas analyzer (BGA). When a control measurement by BGA results in a glucose level of <2.2 or >25 mmol/l, the value will be transmitted to the Patient Data Management System (PDMS) and gives an alarm. Otherwise, the value will be blinded in the PDMS.

Freestyle Navigator data will be downloaded from the device. Blood glucose values obtained in the course of usual care will be compared with time-matched Freestyle Navigator values to assess device accuracy.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

178

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Holland
      • Amsterdam, Holland
        • Onze Lieve Vrouwe Gasthuis

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:

  • ICU-patients > 18 years
  • Expected length of stay on the ICU > 24 hours
  • Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
  • Availability of the Freestyle Navigator

Exclusion Criteria:

  • Participation in another trial subject to the WMO
  • Lack of informed consent
  • Contraindication for the use of the Accu Chek (for example peritoneal dialysis, Ht <0,20 of > 0,65; paracetamol intoxication)
  • Contraindication for placement of the subcutaneous glucose sensor
  • Participation in this trial during previous ICU admittance

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Freestyle group
Glucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU
Enhed: Freestyle Navigator
Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
Andre navne:
  • Freestyle Navigator, Abbott Diabetes Care
Aktiv komparator: AccuChek group
Glucose levels are being measured by the AccuChek. Patients also get a Freestyle Navigator, which will be blinded. The device will stay on the patient up to 5 days, or until discharge from the ICU.
Enhed: Freestyle Navigator
Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
Andre navne:
  • Freestyle Navigator, Abbott Diabetes Care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dødelighed
Length of stay in the ICU
Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®)
The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol
Time duration that the blood glucose levels of a patient are under and above the 'target range' (measured with the freestyle Navigator®)
The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol
- Variability of the glycemic levels by arterial measuring with the blood gas analyzer (BGA), determined by the Mean Absolute Glucose change per hour (MAG)

Mean Absolute Glucose change per hour:

ΔBGA / Δtime The MAG is calculated by taking the sum of all absolute glucose changes during admission (measured by BGA) and dividing this by the total time spent in the ICU in hours.
False positive frequency of alarms of the Freestyle Navigator®
Verified by the glucose level measurements by blood gas analyzer
Number of undesirable low glucose levels per 24 hours
Tidsramme: 24 hours
blood glucose levels between 2,5 and 5 mmol/l
24 hours
Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®)
Number of blood samples per day
Tidsramme: 24 hours
24 hours

Samarbejdspartnere og efterforskere

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

Sponsor

Onze Lieve Vrouwe Gasthuis

Efterforskere

  • Ledende efterforsker: P HJ van der Voort, MD, PhD, Onze Lieve Vrouwe Gasthuis

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

1. december 2010

Primær færdiggørelse (Faktiske)

1. april 2012

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

1. februar 2012

Først indsendt, der opfyldte QC-kriterier

1. februar 2012

Først opslået (Skøn)

3. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. juni 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2012

Sidst verificeret

1. juni 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NL33495.100.10

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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