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
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock Acute Kidney Injury||Other: Standard of Care Drug: Angiotensin II||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- Time to discontinuation of catecholamines [ Time Frame: Until shock resolution, up to 14 days ]Time from enrollment to discontinuation of catecholamines
- 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).
- In-hospital mortality [ Time Frame: Up to 3 months following enrollment ]Assessment of all-cause mortality within hospital admission
- Renal replacement therapy-free days [ Time Frame: Within 28 days of enrollment ]Days free of renal replacement therapy from enrollment up to day 28
- 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
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
|Contact: Alexander H Flannery, Pharm.D.||firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Alexander H Flannery, Pharm.D.||University of Kentucky|