Phenotype Guided Vasoactive Medication During Kidney Transplantation

Jennifer Cutler

Status and phase: Invitation-only; Phase 4

Conditions: Fluid Management; Kidney Transplant

Treatments: Drug: Phenotype-Guided Vasoactive Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07633600

IRB Study 4762

Details and patient eligibility

About

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.

Full 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.

Enrollment: 255 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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255 participants in 1 patient group

Experimental: Phenotype-Guided Vasoactive Protocol

Experimental group

Description:

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.

Treatment:

Drug: Phenotype-Guided Vasoactive Management