Phenotype Guided Vasoactive Medication During Kidney Transplantation

NCT07633600 | Not Yet Recruiting Phase 4

• 1 other identifier: IRB Study 4762
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fluid Management; Kidney Transplant

Keywords

Vasoactive Management; Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  intraoperative

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

  intraoperative

• Protocol Adherence

  Intraoperative

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

  intraoperative

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

  intraoperative

Study Arms (1)

Experimental: Phenotype-Guided Vasoactive Protocol

EXPERIMENTAL

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

Interventions

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.

Also known as: Norepinephrine, Calcium Chloride, Dopamine, Vasopressin

Experimental: Phenotype-Guided Vasoactive Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jennifer Cutler: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Norepinephrine; Calcium Chloride; Dopamine; Vasopressins

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Calcium Compounds; Inorganic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Jennifer L Cutler, M.D.

CONTACT

310-497-4541; jennifer.cutler@cshs.org

Leon Wang, M.D.

CONTACT

203-464-8236; leon.wang@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication

Locations

US (1)