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Phenotype Guided Vasoactive Medication During Kidney Transplantation

4. juni 2026 oppdatert av: Jennifer Cutler

Intraoperative Circulation Phenotyping to Guide Vasoactive Medication in Kidney Transplant Recipients

The goal of this clinical trial is to learn if vasopressin improves the body's response to intravenous fluids during kidney transplantation in patients who have relaxed blood vessels. Researchers will compare the results of vasopressin to those who received calcium chloride.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This prospective, single-arm interventional study evaluates a phenotype-guided vasoactive protocol during adult kidney transplantation. Intraoperative monitoring includes pulse contour analysis and repeated FPC testing. Based on predefined phenotype criteria, vasoactive support is assigned as follows: vasopressin infusion for Hyperdynamic physiology, norepinephrine infusion for Mixed Physiology, calcium chloride boluses and/or low-dose dopamine infusion for Poor Contractility, and fluid-guided management for Normal physiology.

Studietype

Intervensjonell

Registrering (Antatt)

255

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90048
        • Cedars Sinai Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 years or older
  • Undergoing kidney transplantation at Cedars-Sinai Medical Center
  • Able to provide informed consent

Exclusion Criteria:

  • Patients unable to provide informed consent
  • Patients with contraindications to protocol vasoactive medications, as determined by the treating anesthesiologist
  • Patients in whom required intraoperative monitoring cannot be performed

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Experimental: Phenotype-Guided Vasoactive Protocol
Recipients undergo intraoperative circulation phenotyping using pulse contour monitoring and fluid responsiveness testing. Vasoactive support is assigned according to phenotype: vasopressin infusion for Hyperdynamic physiology, norepinephrine infusion for Mixed Physiology, calcium chloride and/or low-dose dopamine for Poor Contractility, and fluid-guided support for Normal physiology.
Legemiddel: Phenotype-Guided Vasoactive Management
Recipients undergo intraoperative circulation phenotyping using pulse contour monitoring and flow-pressure coupling testing. Vasoactive support is assigned according to phenotype: vasopressin infusion for Hyperdynamic physiology, norepinephrine infusion for Mixed Physiology, calcium chloride and/or low-dose dopamine for Poor Contractility, and fluid-guided support for Normal physiology.
Andre navn:
  • Noradrenalin
  • Dopamin
  • Vasopressin
  • Calcium Chloride

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Positive Flow-Pressure Coupling Proportion in Hyperdynamic Phenotype as measured by pulse contour analysis on the Edwards Hemosphere
Tidsramme: Intraoperative (from induction to end of surgery)
Proportion of positive flow-pressure coupling responses among recipients classified intraoperatively as Hyperdynamic. Flow-Pressure coupling is defined as demonstrating both fluid responsiveness and pressure responsiveness following a fluid responsiveness test. Fluid responsiveness is defined as >= 10% increase in the stroke volume (ml/beat) and pressure responsiveness is defined as >= 15% in the mean arterial pressure (mmHg) 2 minutes after conclusion of the fluid responsiveness test. Hyperdynamic phenotypes are defined as having the following hemodynamics: CI >4.0 L/min/m², SVRI <1970 dyn·s·cm-⁵/m², and dP/dt >1000 mmHg/s .
Intraoperative (from induction to end of surgery)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Characterization of flow-pressure coupling in Normal, Mixed Physiology, and Poor-contractility phenotypes as measured with pulse contour analysis on the Edwards Hemosphere
Tidsramme: intraoperative
Measurement of positive rate of FPC per FRT in all remaining circulatory phenotypes. These phenotypes are defined by the following hemodynamics: • Normal phenotype: CI 2.5-4.0 L/min/m² and SVRI 1970-2390 dyn·s·cm-⁵/m² ; • Mixed physiology: CI 2.5-4.0 L/min/m², SVRI <1970 dyn·s·cm-⁵/m², and dP/dt <1000 mmHg/s and • Poor Contractility: CI <2.5 L/min/m² and dP/dt <1000 mmHg/s .
intraoperative
Analysis of intraoperative cardiac index (CI) measured with pulse contour analysis on the Edwards Hemosphere
Tidsramme: intraoperative
recording of CI L/min/m² as baseline, and after each FRT
intraoperative
Protocol Adherence
Tidsramme: Intraoperative
Proportion of intraoperative decision points consistent with the phenotype-guided protocol.
Intraoperative
Analysis of Intraoperative Systemic vascular resistance index (SVRI) measured with pulse contour analysis on the Edwards Hemosphere
Tidsramme: intraoperative
Recording of SVRI dyn·s·cm-⁵/m² as baseline, and after each FRT
intraoperative
Analysis of Intraoperative mean arterial pressure (MAP) measured with pulse contour analysis on the Edwards Hemosphere
Tidsramme: intraoperative
recording of MAP mmHg as baseline and after each FRT
intraoperative
Analysis of Intraoperative Contractility (dP/dt) measured with pulse contour analysis on the Edwards Hemosphere.
Tidsramme: intraoperative
Recording of dP/dt mmHg/s as baseline and after each FRT
intraoperative
Analysis of Intraoperative EaDyn (PPV/SVV) with pulse contour analysis on the Edwards Hemosphere
Tidsramme: intraoperative
Recording of EaDyn (PPV/SVV) as baseline and after each FRT
intraoperative
Recording of delayed graft function, defined as the need for dialysis within the first week following kidney transplantation
Tidsramme: Postoperative day 0 to postoperative day 7
Delayed graft function will be recorded as yes or no
Postoperative day 0 to postoperative day 7

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Jennifer Cutler

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

27. mars 2026

Først innsendt som oppfylte QC-kriteriene

4. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB Study 4762

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

all IPD that underlie results in a publication

IPD-delingstidsramme

starting 6 months after publication

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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