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Kidney TransplantPhase 4NCT07633600

Phenotype Guided Vasoactive Medication During Kidney Transplantation

A Phase 4 study testing Phenotype-Guided Vasoactive Management in people with Kidney Transplant and Fluid Management, run by Jennifer Cutler at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplant, Fluid Management
What is being tested?
Phenotype-Guided Vasoactive Management
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
1 siteUnited States
Study dates
1 Jun 2026to 1 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Phenotype-Guided Vasoactive Management
Keywords
Vasoactive Management, Kidney Transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phenotype-Guided Vasoactive ManagementDrug

    Also called Norepinephrine, Calcium Chloride, Dopamine, Vasopressin

    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.

Study groups in NCT07633600
Study groupRoleWhat they receive
Experimental: Phenotype-Guided Vasoactive ProtocolExperimentalRecipients 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.
Receives: Drug: Phenotype-Guided Vasoactive Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 .

    Measured: Intraoperative (from induction to end of surgery)

Secondary outcomes (8)

  1. 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 .

    Measured: intraoperative

  2. 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

    Measured: intraoperative

  3. Protocol Adherence

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

    Measured: Intraoperative

  4. 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

    Measured: intraoperative

  5. 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

    Measured: intraoperative

  6. 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

    Measured: intraoperative

  7. 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

    Measured: intraoperative

  8. 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

    Measured: Postoperative day 0 to postoperative day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2026
  2. Study start1 Jun 2026
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
255 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07633600
Sponsor's protocol ID
IRB Study 4762
Status last verified
Oct 2026
First submitted
27 Mar 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Phenotype-Guided Vasoactive Management in people with Kidney Transplant and Fluid Management, run by Jennifer Cutler at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07633600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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