Fluid Management, Kidney Transplant
Conditions
Keywords
Vasoactive Management, Kidney Transplant
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.
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.
Interventions
DRUGPhenotype-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.
Sponsors
Jennifer Cutler
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Flow-Pressure Coupling Proportion in Hyperdynamic Phenotype as measured by pulse contour analysis on the Edwards Hemosphere | Intraoperative (from induction to end of surgery) | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of flow-pressure coupling in Normal, Mixed Physiology, and Poor-contractility phenotypes as measured with pulse contour analysis on the Edwards Hemosphere | intraoperative | 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 . |
| Analysis of intraoperative cardiac index (CI) measured with pulse contour analysis on the Edwards Hemosphere | intraoperative | recording of CI L/min/m² as baseline, and after each FRT |
| Protocol Adherence | Intraoperative | Proportion of intraoperative decision points consistent with the phenotype-guided protocol. |
| Analysis of Intraoperative Systemic vascular resistance index (SVRI) measured with pulse contour analysis on the Edwards Hemosphere | intraoperative | Recording of SVRI dyn·s·cm-⁵/m² as baseline, and after each FRT |
| Analysis of Intraoperative mean arterial pressure (MAP) measured with pulse contour analysis on the Edwards Hemosphere | intraoperative | recording of MAP mmHg as baseline and after each FRT |
| Analysis of Intraoperative Contractility (dP/dt) measured with pulse contour analysis on the Edwards Hemosphere. | intraoperative | Recording of dP/dt mmHg/s as baseline and after each FRT |
| Analysis of Intraoperative EaDyn (PPV/SVV) with pulse contour analysis on the Edwards Hemosphere | intraoperative | Recording of EaDyn (PPV/SVV) as baseline and after each FRT |
| Recording of delayed graft function, defined as the need for dialysis within the first week following kidney transplantation | Postoperative day 0 to postoperative day 7 | Delayed graft function will be recorded as yes or no |
Countries
United States
Contacts
CONTACTJennifer L Cutler, M.D.
CONTACTLeon Wang, M.D.
Outcome results
None listed