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Not yet recruiting NCT07633600

Phenotype Guided Vasoactive Medication During Kidney Transplantation

Phase IV Interventional Kidney Transplant Fluid Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phenotype-Guided Vasoactive Management.
Who it may be relevant to
Registry conditions: Kidney Transplant, Fluid Management. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Intraoperative Circulation Phenotyping to Guide Vasoactive Medication in Kidney Transplant Recipients

Overview

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.

Detailed description

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.

Interventions

  • Drug 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (8)
  • 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]
  • Analysis of intraoperative cardiac index (CI) measured with pulse contour analysis on the Edwards Hemosphere [Time frame: intraoperative]
  • Protocol Adherence [Time frame: Intraoperative]
  • Analysis of Intraoperative Systemic vascular resistance index (SVRI) measured with pulse contour analysis on the Edwards Hemosphere [Time frame: intraoperative]
  • Analysis of Intraoperative mean arterial pressure (MAP) measured with pulse contour analysis on the Edwards Hemosphere [Time frame: intraoperative]
  • Analysis of Intraoperative Contractility (dP/dt) measured with pulse contour analysis on the Edwards Hemosphere. [Time frame: intraoperative]
  • Analysis of Intraoperative EaDyn (PPV/SVV) with pulse contour analysis on the Edwards Hemosphere [Time frame: intraoperative]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Cedars Sinai Medical Center — Los Angeles

Identifiers

NCT: NCT07633600 · IRB Study 4762

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗