Phenotype Guided Vasoactive Medication During Kidney Transplantation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Transplant; Fluid Management
• Intervention / Treatment: Drug: Phenotype-Guided Vasoactive Management

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.

• Study Type: Interventional
• Enrollment (Estimated): 255
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jennifer L Cutler, M.D.; Phone Number: 310-497-4541; Email: jennifer.cutler@cshs.org
• Study Contact Backup: Name: Leon Wang, M.D.; Phone Number: 203-464-8236; Email: leon.wang@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.; Other Names: Norepinephrine; Dopamine; Vasopressin; Calcium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Flow-Pressure Coupling Proportion in Hyperdynamic Phenotype as measured by pulse contour analysis on the Edwards Hemosphere	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of flow-pressure coupling in Normal, Mixed Physiology, and Poor-contractility phenotypes as measured with pulse contour analysis on the Edwards Hemosphere	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	recording of CI L/min/m² as baseline, and after each FRT	intraoperative
Protocol Adherence	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	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	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.	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	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	Delayed graft function will be recorded as yes or no	Postoperative day 0 to postoperative day 7

Collaborators and Investigators

• Sponsor: Jennifer Cutler

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Kidney Transplant; Vasoactive Management
• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Inorganic Chemicals; Chlorine Compounds; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Calcium Compounds; Pituitary Hormones, Posterior; Pituitary Hormones; Chlorides; Hydrochloric Acid; Norepinephrine; Vasopressins; Dopamine; Calcium Chloride
• Other Study ID Numbers: IRB Study 4762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No