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Phenotype Guided Vasoactive Medication During Kidney Transplantation

ConditionsKidney TransplantFluid Management
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJennifer Cutler

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older

Undergoing kidney transplantation at Cedars-Sinai Medical Center

Able to provide informed consent

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

255 Participants
are divided into 1 treatment group
Group A: Experimental: Phenotype-Guided Vasoactive ProtocolExperimental treatment 1 intervention

Trial outcomes

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 .

Time frame
Intraoperative (from induction to end of surgery)

Secondary outcomes

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 .

Time frame
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

Time frame
intraoperative
3

Protocol Adherence

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

Time frame
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

Time frame
intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jennifer Cutler

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: