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NCT Number: NCT07633600

Phenotype Guided Vasoactive Medication During Kidney Transplantation

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.

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Key information

Conditions

Kidney Transplant Fluid Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenotype-Guided Vasoactive Management

Drug

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.

Other names: Norepinephrine, Calcium Chloride, Dopamine, Vasopressin

Primary outcomes

  1. Positive Flow-Pressure Coupling Proportion in Hyperdynamic Phenotype as measured by pulse contour analysis on the Edwards Hemosphere

    Time frame: 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 .

Secondary outcomes

  1. Characterization of flow-pressure coupling in Normal, Mixed Physiology, and Poor-contractility phenotypes as measured with pulse contour analysis on the Edwards Hemosphere

    Time frame: 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 .

  2. Analysis of intraoperative cardiac index (CI) measured with pulse contour analysis on the Edwards Hemosphere

    Time frame: intraoperative

    recording of CI L/min/m² as baseline, and after each FRT

  3. Protocol Adherence

    Time frame: Intraoperative

    Proportion of intraoperative decision points consistent with the phenotype-guided protocol.

  4. Analysis of Intraoperative Systemic vascular resistance index (SVRI) measured with pulse contour analysis on the Edwards Hemosphere

    Time frame: intraoperative

    Recording of SVRI dyn·s·cm-⁵/m² as baseline, and after each FRT

  5. Analysis of Intraoperative mean arterial pressure (MAP) measured with pulse contour analysis on the Edwards Hemosphere

    Time frame: intraoperative

    recording of MAP mmHg as baseline and after each FRT

  6. Analysis of Intraoperative Contractility (dP/dt) measured with pulse contour analysis on the Edwards Hemosphere.

    Time frame: intraoperative

    Recording of dP/dt mmHg/s as baseline and after each FRT

  7. Analysis of Intraoperative EaDyn (PPV/SVV) with pulse contour analysis on the Edwards Hemosphere

    Time frame: intraoperative

    Recording of EaDyn (PPV/SVV) as baseline and after each FRT

  8. Recording of delayed graft function, defined as the need for dialysis within the first week following kidney transplantation

    Time frame: Postoperative day 0 to postoperative day 7

    Delayed graft function will be recorded as yes or no

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer L Cutler, M.D.

CONTACT

[email protected]

310-497-4541

Leon Wang, M.D.

CONTACT

[email protected]

203-464-8236

Sponsors and collaborators

Lead sponsor

Jennifer Cutler

Other

Registry information

Official study title

Intraoperative Circulation Phenotyping to Guide Vasoactive Medication in Kidney Transplant Recipients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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