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Vasopressor
Angiotensin II for Septic Shock (DARK-Sepsis Trial)
Phase 4
Recruiting
Led By Joao P Teixeira, MD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours post drug initiation or soc equivalent
Awards & highlights
DARK-Sepsis Trial Summary
This trial will compare angiotensin II to current treatment for shock, to see if novel biomarkers can predict blood pressure response. Unblinded study.
Who is the study for?
Adults over 18 with persistent vasodilatory shock despite certain treatments, who have specific catheters in place and are not fluid responsive. They must be able to consent or have a representative do so, and not fall under exclusion criteria like acute stroke, severe liver failure, high-dose steroid use, extensive burns, very low neutrophils count, active bleeding with low hemoglobin levels or conditions contraindicating blood sampling.Check my eligibility
What is being tested?
The trial is testing if angiotensin II can better manage blood pressure in adults with septic shock compared to standard vasopressor therapy. It's also looking at whether two biomarkers can predict the response to this treatment. This unblinded study randomly assigns participants to either receive angiotensin II or stick with the usual care.See study design
What are the potential side effects?
Potential side effects of angiotensin II may include increased blood pressure leading to possible cardiovascular events such as irregular heartbeats or chest pain; it might also affect kidney function and could cause allergic reactions.
DARK-Sepsis Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours post drug initiation or soc equivalent
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours post drug initiation or soc equivalent
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability of baseline DPP3 to predict NED at 3 hours
Ability of baseline renin to predict norepinephrine equivalent dose (NED) at 3 hours
Secondary outcome measures
Ability of changes in DPP3 level to predict NED at 3 hours
Ability of changes in renin level to predict NED at 3 hours
Ability of pre-baseline DPP3 to predict NED at 3 hours
+18 moreOther outcome measures
Prespecified Adverse Events: atrial fibrillation
Prespecified Adverse Events: confirmed infection
Prespecified Adverse Events: hyperglycemia
+14 moreDARK-Sepsis Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Angiotensin IIExperimental Treatment1 Intervention
For patients randomized to the intervention group, once the dose of background norepinephrine reaches ≥0.10 mcg/kg/min for ≥30 minutes, angiotensin II will be started at a dose of 20 ng/kg/min (recommended starting dose in package insert).Thereafter, angiotensin II and norepinephrine will both be titrated to mean arterial pressure (MAP) goal of >/= 65 mmHg according to the protocol titration scheme and in accordance with the University of New Mexico Hospital (UNMH) Nursing Department Titration Guideline. Angiotensin II treatment will be capped at 72 hours, at which point (if a second vasopressor is still needed) the patient will be started on an alternative agent.
Group II: Standard of Care (SOC)Active Control1 Intervention
Vasopressor therapy be titrated by the clinical team per usual SOC and UNMH Nursing Department Titration Guideline. using other available vasopressor agents (e.g., higher-dose norepinephrine, vasopressin, epinephrine, phenylephrine, and/or dopamine). To provide a comparator arm, patients in the SOC will have renin and DPP3 levels obtained at equivalent timepoints.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Angiotensin II
2010
Completed Phase 4
~260
Find a Location
Who is running the clinical trial?
University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,749 Total Patients Enrolled
1 Trials studying Septic Shock
La Jolla Pharmaceutical CompanyIndustry Sponsor
23 Previous Clinical Trials
2,676 Total Patients Enrolled
3 Trials studying Septic Shock
150 Patients Enrolled for Septic Shock
Joao P Teixeira, MDPrincipal InvestigatorUniversity of New Mexico
1 Previous Clinical Trials
1 Trials studying Septic Shock
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been given fluids as per protocol and no longer respond to them.I have recently had a stroke.I have been diagnosed with a severe heart blockage or shock.I am under 18 years old.I have or might have an abdominal aortic aneurysm or aortic dissection.I am not pregnant, and if I am under 50, I have a negative pregnancy test.I have or had a condition where my intestine's blood supply was blocked.I have asthma or COPD but am not currently experiencing severe symptoms.I or my doctor have decided not to pursue all possible treatments.My liver is failing with a high severity score.I have a blood clot that hasn't been treated or can't take blood clot prevention medication.I have both central venous and arterial catheters installed for at least the first 72 hours of the study.I have a urinary catheter that will stay in for at least 72 hours.I take more than 500 mg of hydrocortisone or a similar medication daily.I do not have active bleeding or a condition that prevents frequent blood tests.My burns cover more than 20% of my body.I am experiencing severe bleeding and might need a significant blood transfusion soon.I am an adult with shock that hasn't improved despite receiving a specific medication.
Research Study Groups:
This trial has the following groups:- Group 1: Angiotensin II
- Group 2: Standard of Care (SOC)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Are there still opportunities to join this clinical research trial?
"As per clinicaltrials.gov, this experiment is currently in the process of enrolling participants with a posted date of April 17th 2023 and most recent update on April 19th 2023."
Answered by AI
What have been the reported adverse effects of Angiotensin II usage?
"Clinical research affirms that angiotensin II is a safe therapy, so it obtained a score of 3."
Answered by AI
What is the aggregate amount of participants engaging in this medical trial?
"Affirmative. According to the data on clinicaltrials.gov, this trial remains open for recruitment since its posting on April 17th 2023 and latest update on April 19th 2023; 40 individuals are required from one site."
Answered by AI
What are the primary aims of this investigation?
"This clinical trial will assess the power of baseline DPP3 levels to predict a "no evidence of disease" outcome 3 hours after drug administration or SOC equivalent time frame. Secondary analyses include exploring the influence of pre-baseline DPP3, changes in renin level, and alterations in DPP3 from pre-baseline to baseline on the same patient outcomes; all these variables with treatment arm (AngII vs. SOC) and baseline SOFA scores as covariables."
Answered by AI
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