Vasoactive Medication for Kidney Transplant

JL
LW
Overseen ByLeon Wang, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Jennifer Cutler
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if vasopressin, a medication that tightens blood vessels, can enhance the body's response to fluids during kidney transplant surgery. Researchers will compare its effectiveness to another treatment, calcium chloride. Participants will receive treatments based on their blood flow type: vasopressin, norepinephrine, calcium chloride, or fluids. This method is part of a phenotype-guided vasoactive management strategy. Individuals undergoing a kidney transplant at Cedars-Sinai Medical Center who can consent might be suitable for this trial. As a Phase 4 trial, this research focuses on an FDA-approved treatment to understand its benefits for more patients, offering participants the chance to contribute to improved care strategies.

What is the safety track record for the treatments in this trial?

Research has shown that the treatments in this trial, such as vasopressin and norepinephrine, have long been used in hospitals. Vasopressin helps improve blood flow and maintain steady blood pressure during surgeries. Norepinephrine also supports blood pressure.

Patients usually tolerate these treatments well. Although all medical treatments can have side effects, serious issues are rarely reported when these medications are used carefully in controlled settings like surgeries. Monitoring the body's response during treatment is crucial, so this trial includes close observation to ensure safety.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the phenotype-guided vasoactive management protocol because it personalizes treatment during kidney transplants based on the patient's unique circulatory profile. Unlike standard care that typically uses a one-size-fits-all approach with medications like norepinephrine or dopamine, this protocol tailors the vasoactive support—using vasopressin, norepinephrine, calcium chloride, or fluid-guided support—according to the patient's specific physiological needs. This individualized approach aims to optimize blood flow and improve transplant outcomes, potentially setting a new standard for kidney transplant surgeries.

What evidence suggests that this trial's treatments could be effective for kidney transplantation?

Research has shown that a personalized approach to managing blood flow during kidney transplants can lead to better outcomes. In this trial, participants will follow a phenotype-guided vasoactive protocol, selecting medications based on individual blood circulation patterns. For instance, vasopressin helps those with hyperdynamic physiology by narrowing blood vessels to maintain steady blood pressure during surgery. Studies also indicate that the right combination of fluids and medications can reduce post-transplant complications. Overall, this approach aims to enhance kidney function and recovery for transplant patients.678910

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who are having a kidney transplant at Cedars-Sinai Medical Center and can give informed consent.

Inclusion Criteria

I am having a kidney transplant at Cedars-Sinai Medical Center.
I am 18 years old or older.
Able to provide informed consent

Exclusion Criteria

I cannot safely take the study's blood pressure medications.
I am unable to give informed consent for my treatment.
Patients in whom required intraoperative monitoring cannot be performed

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative

Participants undergo intraoperative circulation phenotyping and receive phenotype-guided vasoactive medication during kidney transplantation

Duration of surgery
1 visit (in-person)

Postoperative Follow-up

Participants are monitored for delayed graft function and other postoperative outcomes

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Phenotype-Guided Vasoactive Management

Trial Overview

The study compares two ways to manage blood pressure during kidney transplants: using vasopressin based on the patient's condition versus giving calcium chloride. The goal is to see which method helps fluids work better in patients with relaxed blood vessels.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Experimental: Phenotype-Guided Vasoactive ProtocolExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jennifer Cutler

Lead Sponsor

Cedars-Sinai Medical Center

Collaborator

Trials
523
Recruited
165,000+

Citations

Pediatric Renal Transplants: Effects of Intraoperative ...

Physiological management during pedi- atric renal transplants may affect outcomes secondary to intraoperative organ perfusion. There was a significant negative ...

Perioperative fluid management in renal transplantation

Fluid therapy has been shown to be effective for preventing ARF in cer- tain clinical scenarios. However, in acute tubular necrosis. (ATN), only supportive care ...

Fluid Management During Kidney Transplantation

Intraoperative fluid management may affect the outcome after kidney transplantation. starch solutions are associated with increased risk of ...

Perioperative fluid management in kidney transplantation

In this review, we will discuss the different types of fluids and hemodynamic tools available for perioperative fluid management in kidney ...

Perioperative Fluid Management in Kidney Transplant | PDF

Novel minimally invasive technologies seem to reliably assess volume responsiveness, heart function and perfusion adequacy.

Phenotype Guided Vasoactive Medication During Kidney ...

The goal of this clinical trial is to learn if vasopressin improves the body's response to intravenous fluids during kidney transplantation ...

Phenotype Guided Vasoactive Medication... | Clinical Trial

This prospective, single-arm interventional study evaluates a phenotype-guided vasoactive protocol during adult kidney transplantation.

Distinct Phenotypes of Kidney Transplant Recipients in ... - PMC

Despite having a low KPS, 5-year patient survival was 79.1 and 83.9% for clusters 1 and 2; 5-year death-censored graft survival was 86.9 and 91 ...

1.-Kidney-Transplantation-2024.pdf

United States Renal Data System (USRDS) data evaluating survival outcomes of 19,208 kidney transplant recipients who experienced primary ...

Assessment and Management of the Kidney Transplant ...

Between 2008 and 2015, 1-year graft survival was 93.2% for deceased donor transplants and 97.5% for living donor transplants.