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The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation

24. december 2013 opdateret af: Jong Hwan Lee, Samsung Medical Center
The purpose of this study is to investigate whether upper limb ischemic postconditioning can improve renal function and decrease ischemic-reperfusion injury in patients undergoing living donor kidney transplantation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Ischemic reperfusion injury after kidney transplantation is a common clinical problem associated with a high morbidity and mortality. To reduce the adverse effect of ischemic reperfusion injury after organ transplantation, various strategies including ischemic preconditioning or postconditioning. Remote ischemic postconditioning is one of such strategies where brief ischemic reperfusion injury of one organ protects other organs from sustained ischemic reperfusion injury. Remote ischemic postconditioning of the limb with a tourniquet is a safe and convenient method of postconditioning organs against ischemic reperfusion injury. However, the efficacy of remote ischemic postconditioning in patients undergoing living donor kidney transplantation needs to be established. Therefore, we investigate the efficacy of remote ischemic postconditioning of the upper limb with a tourniquet in recipients of kidney transplantation by measuring the markers of acute kidney injury.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 135-710
        • Samsung Seoul Hospital, Samsung Medical Center

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

20 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects undergoing elective living donor kidney transplantation
  • subjects older than 20 yrs who can give written informed consent

Exclusion Criteria:

  • re-transplant recipients
  • those with peripheral vascular disease affecting the upper limbs free of arteriovenous fistula

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Remote ischemic postconditioning group
Recipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation
Enhed: remote ischemic postconditioning
Remote ischemic postconditioning consists of three 5-min cycles of upper limb ischemia, which was induced by an automated cuff-inflator placed on the upper limb free of arteriovenous fistula and inflated to 250 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Ingen indgriben: Control group
Patients who have a deflated cuff placed on the upper limb free of arteriovenous fistula during the surgery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
renal function of recipient after living-related kidney transplantation
Tidsramme: 1 day before surgery
serum creatinine concentration and urine output
1 day before surgery
renal function of recipient after living-related kidney transplantation
Tidsramme: at 2 h after declaming of renal artery
serum creatinine concentration and urine output
at 2 h after declaming of renal artery
renal function of recipient after living-related kidney transplantation
Tidsramme: at 6 h after declaming of renal artery
serum creatinine concentration and urine output
at 6 h after declaming of renal artery
renal function of recipient after living-related kidney transplantation
Tidsramme: at 12 h after declaming of renal artery
serum creatinine concentration and urine output
at 12 h after declaming of renal artery
renal function of recipient after living-related kidney transplantation
Tidsramme: at 24 h after declaming of renal artery
serum creatinine concentration and urine output
at 24 h after declaming of renal artery
renal function of recipient after living-related kidney transplantation
Tidsramme: at 48 h after declaming of renal artery
serum creatinine concentration and urine output
at 48 h after declaming of renal artery
renal function of recipient after living-related kidney transplantation
Tidsramme: at 72 h after declaming of renal artery
serum creatinine concentration and urine output
at 72 h after declaming of renal artery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biomarkers of acute kidney injury
Tidsramme: before surgery and at 2, 6, 12 h after declaming of renal artery
biomarkers of acute kidney injury: Plasma cystatin-C, Urine IL-18, Urine Neutrophil gelatinase-associated lipocalin (NGAL)
before surgery and at 2, 6, 12 h after declaming of renal artery
Hemodynamic parameters
Tidsramme: before surgery and at 2, 6, 12, 24, 48, 72 h after declaming of renal artery
arterial blood pressure, heart rate, central venous pressure, pulse oximetry
before surgery and at 2, 6, 12, 24, 48, 72 h after declaming of renal artery
outcome of kidney transplantation
Tidsramme: at 72 h after declaming of renal artery
number of acute rejection or number of delayed graft function
at 72 h after declaming of renal artery
postoperative hospital stay
Tidsramme: at postoperative day 60
length of postoperative hospital stay (days)
at postoperative day 60

Samarbejdspartnere og efterforskere

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

Sponsor

Samsung Medical Center

Efterforskere

  • Studieleder: Jong Hwan Lee, M.D.,Ph.D., Samsung Medical Center

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. august 2011

Primær færdiggørelse (Faktiske)

1. maj 2012

Studieafslutning (Faktiske)

1. maj 2012

Datoer for studieregistrering

Først indsendt

23. maj 2011

Først indsendt, der opfyldte QC-kriterier

31. maj 2011

Først opslået (Skøn)

1. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. december 2013

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2011-03-047

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 Nyretransplantation

Kliniske forsøg med remote ischemic postconditioning

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