Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
9. marts 2012 opdateret af: Jan Blaha, Charles University, Czech Republic
A randomized trial to compare three insulin-titration protocols for tight glycemic control in surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath) protocol, and an enhanced model predictive control algorithm (eMPC)
Studieoversigt
Detaljeret beskrivelse
120 consecutive post-cardiac surgery patients randomized to the three protocols with a target glycemia range from 4.4 to 6.1 mmol/l.
Intravenous insulin was administered continuously or in combination with insulin boluses (Matias protocol).
Blood glucose was measured in 1-4 hour intervals as requested by protocols.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Prague, Tjekkiet
- University Hospital in Prague
-
-
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 til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- patients admitted to the postoperative ICU after elective cardiac surgery
Exclusion Criteria:
- insulin allergy
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: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Matias protocol
A protocol based on the absolute glucose value - Matias protocol (Matias)
|
Insulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol).
A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used.
In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started.
In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated.
Andre navne:
|
|
Aktiv komparator: Bath protocol
A protocol based on the relative glucose change - Bath protocol (Bath)
|
Insulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol).
A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used.
In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started.
In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated.
Andre navne:
|
|
Aktiv komparator: eMPC
a computer-based model predictive control algorithm with variable sampling rate (eMPC)
|
Insulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol).
A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used.
In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started.
In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The effectiveness of different TGC management protocols
Tidsramme: ICU stay
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ICU stay
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The safety with respect to hypoglycemia
Tidsramme: ICU stay
|
ICU stay
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jan Blaha, MD, Charles University, Czech Republic
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
- Blaha J, Kopecky P, Kotulak T, Kunstyr J, Matias M, Rubes D, Dobias M, Romaniv S, Kubatova J, Porizka M et al: Blood glucose control in cardiac surgery patients: a comparative study of different insulin protocols. Journal of Cardiothoracic and Vascular Anesthesia 2008, 22(S3):S23.
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. februar 2008
Primær færdiggørelse (Faktiske)
1. april 2008
Studieafslutning (Faktiske)
1. april 2008
Datoer for studieregistrering
Først indsendt
1. oktober 2008
Først indsendt, der opfyldte QC-kriterier
1. oktober 2008
Først opslået (Skøn)
2. oktober 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. marts 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. marts 2012
Sidst verificeret
1. marts 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- POINT-protocols
- GAUK no. 44407
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 .