NCT04904562

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled pilot study. A total of 40 patients who develop distributive shock, intra-operatively or post-operatively within 48 hours of heart transplant or left ventricular assist device placement will be enrolled. Participants will be randomized to Angiotensin II (Giapreza) vs. placebo plus standard of care, as a first line agent for vasoplegia. Two groups of patients will be enrolled:

  • Group A: Heart Transplant (10 control, 10 treatment)
  • Group B: LVAD implant (10 control, 10 treatment)

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

May 12, 2021

Results QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Distributive Shock

Keywords

Vasoplegia

Outcome Measures

Primary Outcomes (1)

  • Total Catecholamine Dose

    Total catecholamine dose for first 24 hours after distributive shock is first diagnosed

    24 hours

Secondary Outcomes (10)

  • Cumulative Time Spent With MAP < 70 mmHg

    24 hours

  • Time to Extubation

    24 hours

  • Incidence of Stroke

    48 hours

  • Incidence of Acute Kidney Injury

    48 hours

  • Incidence of New Tachyarrhythmia

    24 hours

  • +5 more secondary outcomes

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Angiotensin II administered as an intravenous (IV) infusion will be increased every 5 minutes by 5-10ng/kg/min increments up to 80ng/kg/min

Drug: Angiotensin II

Control

PLACEBO COMPARATOR

Intravenous (IV) infusion (saline)

Drug: Placebo

Interventions

Angiotensin IIDRUG

Angiotensin II started at 5 ng/kg/min and titrated in 5-10 ng/kg/min increments every 5 minutes up to 80ng/kg/min to achieve target arterial pressure (MAP)

Also known as: Giapreza
Treatment
PlaceboDRUG

Placebo

Also known as: Saline solution
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients (18 years of age or older)
  • Onset of distributive shock within 48 hours after heart transplantation or VAD placement. Distributive shock defined as MAP less than 55mmHg on CPB, MAP less than 70mmHg before or after CPB, or systemic vascular resistance (SVR) less than 800 dynes/cm/sec5 with cardiac index (CI) greater than 2.0L/min/m2 and clinically determined euvolemia.

You may not qualify if:

  • Patients without distributive shock,
  • Women who are pregnant or breastfeeding.
  • Patients who do not receive the study drug as a first line agent for distributive shock
  • Allergy to angiotensin II, angiotensin II or another vasopressor being used at the time of presentation to the operating room
  • Preexisting distributive shock
  • Preexisting thromboembolic disease
  • Patients who are unwilling to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Vasoplegia

Interventions

Angiotensin IIGiaprezaSaline Solution

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AngiotensinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsAutacoidsInflammation MediatorsBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Choy Lewis
Organization
Northwestern University
choy.lewis@northwestern.edu
(312) 695-0061

Study Officials

  • Choy Lewis, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Study medication and matching placebo (saline) administered by IV infusion
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1:1 randomization to receive either study drug or placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 27, 2021

Study Start

June 1, 2022

Primary Completion

May 1, 2024

Study Completion

July 1, 2024

Last Updated

April 13, 2026

Results First Posted

April 13, 2026

Record last verified: 2026-03

Locations

US(1)