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Trial record 3 of 1573 for:    giapreza

Renin and Renal Biomarker Response to Angiotensin II

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ClinicalTrials.gov Identifier: NCT04558359
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Alexander Flannery, University of Kentucky

Brief Summary:
Septic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study. First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock. Several subgroups from the approval trial have indicated that angiotensin II may confer a survival benefit in certain conditions, including those patients requiring continuous renal replacement therapy, those with altered angiotensin I: angiotensin II ratios, and most recently, those with elevated renin levels (which may serve as a surrogate for dysfunctional angiotensin 1: angiotensin II ratios). This open-label, sequential period pilot study will evaluate angiotensin II and biomarker response (renin) in the treatment of septic shock.

Condition or disease Intervention/treatment Phase
Septic Shock Acute Kidney Injury Other: Standard of Care Drug: Angiotensin II Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renin and Renal Biomarker Response to Angiotensin II Versus Controls in Septic Shock: An Open-Label Study
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: Standard of Care Cohort
Patients in this group will receive standard of care treatment.
Other: Standard of Care
These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.

Experimental: Angiotensin II Cohort
Patients in this group will receive angiotensin II.
Drug: Angiotensin II
These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.




Primary Outcome Measures :
  1. Change in Plasma Renin Levels [ Time Frame: Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days) ]
    Plasma renin levels will be measured from blood collected at baseline, 24 hours, and at shock resolution. Additionally, a 3-hour measurement will be included in the angiotensin II arm.


Secondary Outcome Measures :
  1. Change in Renal Biomarkers [ Time Frame: Until shock resolution, up to 14 days (at baseline, 24 hours, and shock resolution, up to 14 days) ]
    Cystatin C, NGAL will be measured from blood collected at baseline, 24 hours, and at shock resolution.

  2. Time to discontinuation of catecholamines [ Time Frame: Until shock resolution, up to 14 days ]
    Time from enrollment to discontinuation of catecholamines

  3. ICU Length of Stay [ Time Frame: From enrollment to ICU discharge, up to 28 days following enrollment ]
    Number of days in the intensive care unit (ICU).

  4. In-hospital mortality [ Time Frame: Up to 3 months following enrollment ]
    Assessment of all-cause mortality within hospital admission

  5. Renal replacement therapy-free days [ Time Frame: Within 28 days of enrollment ]
    Days free of renal replacement therapy from enrollment up to day 28

  6. Safety outcomes [ Time Frame: Up to 72 hours following shock resolution, no longer than 17 days from enrollment ]
    Incidence of venous thromboembolism, arrhythmia, extremity hypoperfusion, delirium, new ischemic event, new infection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical ICU admission
  • Septic shock
  • Norepinephrine requirement = 0.15 mcg/kg/min for = 30 minutes (if cirrhosis, norepinephrine requirement = 0.1 mcg/kg/min for = 30 minutes)
  • Kidney Disease Improving Global Outcomes stage 1 or greater AKI

Exclusion Criteria:

  • Prisoner
  • Pregnancy
  • Acute occlusive coronary syndrome requiring intervention or acute myocardial infarction of any degree
  • Purely cardiogenic shock (no distributive component)
  • Mesenteric ischemia
  • Acute ischemic stroke
  • Hemorrhagic shock
  • Active treatment of hepatorenal syndrome targeting a MAP = 65 mm Hg
  • Planned withdrawal of care within next 24 hours or no escalation of care
  • Patient enrolled in an interventional study
  • High likelihood of medical futility in using this drug:
  • 3 or more vasopressors required to sustain MAP
  • Sustained norepinephrine equivalents > 0.5 mcg/kg/min
  • COVID-19 positive, or high suspicion of COVID-19

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558359


Contacts
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Contact: Alexander H Flannery, Pharm.D. 859-562-2766 alex.flannery@uky.edu

Locations
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United States, Kentucky
University of Kentucky HealthCare Chandler Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Alexander H. Flannery, Pharm.D.    859-323-9078    alex.flannery@uky.edu   
Sponsors and Collaborators
Alexander Flannery
Investigators
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Principal Investigator: Alexander H Flannery, Pharm.D. University of Kentucky
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Responsible Party: Alexander Flannery, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04558359    
Other Study ID Numbers: 57411
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Alexander Flannery, University of Kentucky:
Renin
Angiotensin II
vasopressor
sepsis
Additional relevant MeSH terms:
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Angiotensin II
Giapreza
Shock, Septic
Acute Kidney Injury
Shock
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Angiotensinogen
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action