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Vasoconstrictor
Angiotensin II for Distributive Shock
Phase 4
Recruiting
Led By Choy Lewis, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Patients aged 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new treatment for distributive shock that may help people who have had a heart transplant or implantation of a left ventricular assist device.
Who is the study for?
This trial is for adults who develop distributive shock within 48 hours after a heart transplant or left ventricular assist device (LVAD) placement. They must have specific blood pressure and resistance criteria met, with normal cardiac output. Pregnant or breastfeeding women, those unwilling to consent, patients already on vasopressors before surgery, or with preexisting thromboembolic disease or distributive shock are excluded.Check my eligibility
What is being tested?
The study tests Angiotensin II (Giapreza) against a placebo in managing low blood pressure due to distributive shock post-heart surgery. It's a small-scale test involving 40 patients split into two groups: one for heart transplants and another for LVAD implants, each further divided equally between the drug and placebo.See study design
What are the potential side effects?
Potential side effects of Angiotensin II include increased blood pressure, possible clotting issues, and allergic reactions among others not specified here. The exact side effects will be monitored closely given this is an investigational setting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experienced shock soon after my heart transplant or VAD placement.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total catecholamine dose
Secondary outcome measures
30-day mortality
Cumulative time spent with MAP < 70 mmHg
Fluid overload
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: TreatmentActive Control1 Intervention
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
Group II: ControlPlacebo Group1 Intervention
Intravenous (IV) infusion (saline)
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,191 Total Patients Enrolled
La Jolla Pharmaceutical CompanyIndustry Sponsor
23 Previous Clinical Trials
2,676 Total Patients Enrolled
4 Trials studying Distributive Shock
446 Patients Enrolled for Distributive Shock
Choy Lewis, MDPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experienced shock soon after my heart transplant or VAD placement.I have a condition where my blood flow is not normal, leading to low blood pressure.I am allergic to certain blood pressure medications.I have not used the study drug as the first treatment for my shock condition.I do not have distributive shock.I am not pregnant or breastfeeding.I have a history of blood clots.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Treatment
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree is this therapy hazardous to individuals?
"This therapy has been approved, thus earning a rating of 3 in terms of safety. Notably, this is a Phase 4 trial which provides further assurance that the treatment is safe."
Answered by AI
Are there remaining slots for individuals to join this experiment?
"Confirmed. The details provided on clinicaltrials.gov demonstrate that this investigation is currently accepting participants, having been publicized since June 1st 2022 and modified recently on September 30th 2022. There are 40 spots to be filled from one facility."
Answered by AI
What is the present scale of this medical experiment?
"Indeed, clinicaltrials.gov's records suggest that this trial is currently in the process of recruiting participants. This endeavor was initially posted on June 1st 2022 and most recently updated on September 30th 2022. The study requires a total of 40 individuals to be recruited from one medical centre."
Answered by AI
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