- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03505112
The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy
The Effect of Goal-directed Hemodynamic Therapy on Clinical Outcomes in Patients Undergoing Radical Cystectomy: : A Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Select
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Seoul, Select, Korea, Republikken, 110-744
- Jin-Tae Kim
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients undergoing open radical cystectomy
- Patients with American Society of Anesthesiologists physical status I-III
Exclusion Criteria:
- Significant hepatic dysfunction, significant renal dysfunction (estimated glomerular filtration rate <60 ml/min)
- Congestive heart failure (New York Heart Association scores ≥3), Left Ventricular Ejection Fraction < 35%
- Arrhythmia
- Coagulopathy (PT INR >1.5)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Goal-directed therapy group
The patients in goal-directed therapy (GDT) group will be managed according to the goal-directed therapy protocol during the surgery.
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The patients in GDT group will receive intravenous crystalloid fluid or vasopressor or inotropic agent according to the goal-directed therapy protocol utilizing FloTrac / EV1000 clinical platform (Edwards Lifesciences, Irvine, CA, USA). After induction of anesthesia, the baseline stroke volume index (SVI) is measured and then 200-250 ml of crystalloid is administered over 5-10 minutes. If SVI increase by ≥10%, 200-250 ml of crystalloid is given repeatedly until the increase in SVI <10%. If SVI does not increase by ≥10% and there is no decrease in mean arterial pressure (MAP), revaluate SVI every 10 minutes. Despite an increase in SVI of <10% after fluid challenge, if a decrease in MAP is accompanied by cardiac index (CI) ≤ 2.5 L/min/m2, dobutamine is administered by continuous infusion. If there is a decrease in MAP but no decrease in CI, start low dose norepinephrine continuous infusion.
Andre navne:
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Ingen indgriben: Control group
The patients in control group will be managed according to standard perioperative care.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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A composite of postoperative complications
Tidsramme: through the hospitalization period, an average of 2 weeks
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Total incidence of postoperative complications including gastrointestinal complications, complications of infections, wound complications, cardiac events, thromboembolic complications, genitourinary complications, neurological complications based on the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The incidence of postoperative gastrointestinal complications
Tidsramme: through the hospitalization period, an average of 2 weeks
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Gastrointestinal complications include ileus, constipation, gastric ulcer, anastomic bowel leak according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative complications of infections
Tidsramme: through the hospitalization period, an average of 2 weeks
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Complications of infections include urinary tract infection, sepsis, pneumonia, wound infection according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative wound complications
Tidsramme: through the hospitalization period, an average of 2 weeks
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Wound Complications mean wound dehiscence diagnosed clinically and requiring resuturing, according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative cardiac events
Tidsramme: through the hospitalization period, an average of 2 weeks
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Cardiac events include myocardial infarction, arrhythmia, congestive heart failure, pulmonary edema and transient brain natriuretic peptide increase (serum brain natriuretic peptide values 100-500 pg/ml) according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative thromboembolic complications
Tidsramme: through the hospitalization period, an average of 2 weeks
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Thromboembolic complication means pulmonary embolism evidenced by spiral computerized tomography scanning according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative genitourinary complications
Tidsramme: through the hospitalization period, an average of 2 weeks
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Genitourinary complications include renal dysfunction, renal failure, urinary leakage according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative neurological complications
Tidsramme: through the hospitalization period, an average of 2 weeks
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Neurological complications mean presence of a de novo focal deficit, confusion/delirium according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305. Erratum In: JAMA. 2014 Oct 8;312(14):1473.
- Wuethrich PY, Burkhard FC, Thalmann GN, Stueber F, Studer UE. Restrictive deferred hydration combined with preemptive norepinephrine infusion during radical cystectomy reduces postoperative complications and hospitalization time: a randomized clinical trial. Anesthesiology. 2014 Feb;120(2):365-77. doi: 10.1097/ALN.0b013e3182a44440.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1712-125-909
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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