Recruiting
Phase 1

Regadenoson

Sponsor:

Christine Lau, MD

Code:

NCT03072589

Conditions

Lung Transplant

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Regadenoson infusion

Study Details

Brief summary:

This study will evaluate the maximum safe dose and duration of regadenoson (Lexiscan) that can be given to people who are having a lung transplant. Regadenoson will be given as a continuous IV infusion. All participants in the study will receive a regadenoson infusion beginning in the operating room during the lung transplant procedure. Participants will be assigned a certain dose of regadenoson to be given over a 12 or 24 hour period.

Conditions

Lung Transplant

Study ID

NCT03072589

Start date

Nov 30, 2017

Status verified date

Jun, 2020

Completion date

Aug 1, 2022

Anticipated

Primary completion date

Aug 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects must be undergoing a bilateral lung transplantation for end-stage lung disease and thus meet all criteria to be listed
  • Male or female subject, 18 -75 years of age
  • Subjects must sign a study specific informed consent prior to study entry
  • Subjects must meet all of the following laboratory values:

1. hemoglobin ≥ 6 g/dL,
2. platelets > 75,000/mcL,
3. aspartate aminotransferase (AST/SGOT)/ alanine aminotransferase (ALT /SGPT) < 2.5 X institutional upper limit of normal,
4. serum creatinine < 1.5 mg/dL,
5. INR < 1.5, PTT < 40 seconds

Exclusion Criteria:

  • Subject requires preoperative extracorporeal membrane oxygenation (ECMO)
  • Subject has second degree (Mobitz type I or II) or third-degree AV block or sinus node dysfunction
  • Subject has history of a bleeding diathesis
  • Subject has a history of clinically overt stroke within the past 3 years
  • Subject has a history of severe hypertension not adequately controlled with anti-hypertensive medications (Systolic blood pressure ≥ 200 mmHg and/or Diastolic blood pressure ≥ 110 mmHg)
  • Subjects who are receiving chronic anti-coagulation or anti-platelet therapy that would preclude surgery (prophylactic aspirin is acceptable)
  • Subjects with a history of metastatic cancer
  • Subjects with a history of seizure disorder
  • Subjects who are receiving or have received within 30 days any other investigational agents
  • Subjects who have received theophylline or aminophylline within 12 hours of study dosing

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Regadenoson infusion

Dose escalation of Regadenoson infusion

Interventions

Regadenoson infusion

Dose escalation of Regadenoson when given as an infusion

Primary outcome measure

  • Patient tolerability of assigned dose and duration [ Time Frame: Day 7 ]

Central Contacts and Locations

Central contacts

Amanda Bartosic, MBA

410-328-1641ABartosic@som.umaryland.edu

Jennifer Phillips, RN

434-243-5435jvp8a@virginia.edu

Locations

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Amanda Bartosic, MBA

410-328-1641ABartosic@som.umaryland.edu

Principal Investigator:

Christine Lau, MD

More Information

Sponsor

Christine Lau, MD

Last update posted

Jun 4, 2020

Last verified

Jun, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christine Lau, MD on 2020-06-04.