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The Effect of Dexmedetomidine on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery

6. september 2019 opdateret af: Yonsei University

Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery. Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and postoperative mortality. Aortic surgery is the most risky surgery that causes the postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.

The α1- and α2-adrenergic receptors in the kidney modulate vasoconstrictor and vasodilatory effects, respectively. Agents that attenuate renal vasoconstriction may have potential as renoprotective drugs because vasoconstriction most likely contributes to the pathophysiology of AKI. Clonidine, an α2-agonist, has been shown experimentally to inhibit renin release and cause a diuresis, and it has been evaluated in an experimental AKI model, confirming its potential as a renoprotective agent. Furthermore, it has been already reported that dexmedetomidine, α2-agonist, reduce the impairment of renal function after cardiac operation.

The aim of this study is to examine the association between preoperative dexmedetomidine infusion and the incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

108

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, 03722
        • Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College 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

20 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. the patients undergoing ascending, arch and/or proximal descending aorta surgery with cardiopulmonary bypass
  2. 20 - 100 yrs old

Exclusion Criteria:

  1. having preoperative severe renal dysfunction (eGFR < 15 ml/min per 1.73m2)
  2. Left ventricular-ejection fraction < 30%
  3. Preexisting congestive heart failure
  4. Severe coronary artery disease
  5. Hemodynamically unstable arrhythmia
  6. Cardiogenic shock during perioperative period
  7. Ventricular assist device use
  8. cannot communication because of a language barrier or illiteracy

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: dexmedetomidine
dexmedetomidine, 0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
Medicin: dexmedetomidine
Immediately after the induction of anesthesia, patients in the dexmedetomidine group received dexmedetomidine continuous intravenous (IV) infusion of 0.4 mcg/kg/h until 24 hours after surgery.
Placebo komparator: control
saline, same infusion rate (received equal volume of normal saline), IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
Medicin: saline
same infusion rate (received equal volume of normal saline), IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
Tidsramme: up to 7 days after the aortic surgery
0.3 mg/dl increase in serum creatinine concentration within 48 hours OR, a 50% increase within 7 days postoperatively OR, urine volume < 0.5 ml/kg/h for 6 hours
up to 7 days after the aortic surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
Tidsramme: up to 7 days after the surgery
KDIGO stage 2: Serum creatinine increase to 2-3-fold from baseline OR urine output < 0.5 ml/kg/h for 12h
up to 7 days after the surgery
Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
Tidsramme: up to 7 days after the surgery
KDIGO stage 3: Serum creatinine increase to 3.0-fold from baseline OR Increase in serum creatinine to ≥ 4 mg/dl OR Initiation of renal replacement therapy OR In patients <18 years, decrease in eGFR to < 35 ml/min per 1.73 m2 OR Anuria for ≥ 12h.
up to 7 days after the surgery
major morbidity endpoint
Tidsramme: acute kidney injury - up to 7 days after the surgery; Other - during the hospitalization for surgery
acute kidney injury (same as the primary endpoint), permanent stroke, prolonged ventilator care >24h, deep wound infection, and mortality.
acute kidney injury - up to 7 days after the surgery; Other - during the hospitalization for surgery
postoperative delirium
Tidsramme: up to 7 days after the surgery
delirium - assessed with The American Psychiatric Association's fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or Confusion Assessment Method for the ICU
up to 7 days after the surgery
drug-related adverse events
Tidsramme: hypotension or bradycardia: during surgery; Other - during surgery and 24 hours after surgery
hypotension (mean arterial pressure <60 mmHg) or bradycardia (<50 beats/min) OR the use of vasopressor, inotropes or temporary pacing, OR postoperative arrhythmia
hypotension or bradycardia: during surgery; Other - during surgery and 24 hours after surgery

Samarbejdspartnere og efterforskere

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

Sponsor

Yonsei University

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 (Faktiske)

1. september 2015

Primær færdiggørelse (Faktiske)

6. marts 2019

Studieafslutning (Faktiske)

6. marts 2019

Datoer for studieregistrering

Først indsendt

15. november 2015

Først indsendt, der opfyldte QC-kriterier

16. november 2015

Først opslået (Skøn)

17. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 4-2015-0672

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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