Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Study of Glycemic Control on Liver Transplantation Outcomes

31. oktober 2016 opdateret af: Mark Molitch, Northwestern University

Prospective, Randomized, Open-Label, Controlled Study to Evaluate the Safety and Efficacy of Intensive Glycemic Control on Outcomes Following Liver Transplantation

Many but not all studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. In this study, the investigators propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Many studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. However, some recent studies have not been able to reproduce these benefits and have raised the issue of adverse consequences of hypoglycemia associated with intensive therapy. Our own data show an association of increased graft rejection proportional to postoperative glucose levels in patients who have undergone a liver transplant. Preliminary data suggest that this may improved by better glycemic control using the Glucose Management Service here at Northwestern.

In this study, we propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL. Postoperative glucose management with insulin will be supervised by the Glucose Management Service as is routine, with the only research aspect being the two different glucose targets and the outcome analysis with liver transplant rejection as the primary outcome and infections and hypoglycemia being the principle secondary outcomes.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

164

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University Feinberg School of Medicine

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Require Liver Transplantation
  2. Age 18 - 80
  3. Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious.
  4. Expected survival following transplantation for > 1 year.
  5. Glucose level over 180 mg/dL postoperatively

Exclusion Criteria:

  1. Inability of patient or family member to give informed consent
  2. Not expected to survive for > 1 year following liver transplantation.
  3. Previous liver transplantation
  4. Acute liver failure
  5. Living related donor

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: 140 Group
Insulin treatment to target blood glucose at 140 mg/dl
Medicin: Insulin
Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
Andre navne:
  • aspart insulin
  • glargin insulin
  • Lantus insulin
  • Novolog insulin
  • Detemir insulin
  • Levemir insulin
Aktiv komparator: 180 Group
Insulin treatment to target blood glucose at 180 mg/dl
Medicin: Insulin
Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
Andre navne:
  • aspart insulin
  • glargin insulin
  • Lantus insulin
  • Novolog insulin
  • Detemir insulin
  • Levemir insulin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rejection of Liver Transplant
Tidsramme: within 1 year of transplantation
Liver transplant rejection determined by either biopsy or clinical criteria (>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications
within 1 year of transplantation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hypoglycemia
Tidsramme: Within first 3 days following transplantation
Participants experiencing hypoglycemia (glucose < 70 mg/dL) within the first 3- days following transplantation
Within first 3 days following transplantation
Infection Rates
Tidsramme: Within 1 year following transplantation
Within 1 year following transplantation
Rehospitalization Rates
Tidsramme: Within 1 year following transplantation
Within 1 year following transplantation
Overall Graft Survival at 1 Year
Tidsramme: 1 year following transplantation
1 year following transplantation
Death Within 1 Year
Tidsramme: 1 year
Death following liver transplant between 1 day and 1 year
1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Northwestern University

Efterforskere

  • Ledende efterforsker: Mark E Molitch, M.D., Northwestern University Feinberg School of Medicine

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. april 2009

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. maj 2016

Datoer for studieregistrering

Først indsendt

28. september 2010

Først indsendt, der opfyldte QC-kriterier

28. september 2010

Først opslået (Skøn)

29. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STU00005806

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

Kliniske forsøg med Insulin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Tanzania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner