Trial Outcomes & Findings for Renin and Renal Biomarker Response to Angiotensin II (NCT NCT04558359)
NCT ID: NCT04558359
Last Updated: 2024-09-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)
Results posted on
2024-09-04
Participant Flow
2 enrolled participants in the angiotensin II arm had changes in status that deemed them ineligible for the study and they subsequently did not receive open label angiotensin II.
Participant milestones
| Measure |
Standard of Care Cohort
Patients in this group will receive standard of care treatment.
Standard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
|
Angiotensin II Cohort
Patients in this group will receive angiotensin II.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
18
|
|
Overall Study
COMPLETED
|
10
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Renin and Renal Biomarker Response to Angiotensin II
Baseline characteristics by cohort
| Measure |
Standard of Care Cohort
n=10 Participants
Patients in this group will receive standard of care treatment.
Standard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
|
Angiotensin II Cohort
n=18 Participants
Patients in this group will receive angiotensin II.
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.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
61 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
18 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)Population: Number analyzed in one or more rows may be different from overall number due to participant death which would preclude subsequent measurements. 3-hour sample was only done in the angiotensin II arm.
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.
Outcome measures
| Measure |
Standard of Care Cohort
n=10 Participants
Patients in this group will receive standard of care treatment.
Standard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
|
Angiotensin II Cohort
n=18 Participants
Patients in this group will receive angiotensin II.
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
Baseline Minus 24-Hour Sample
|
-15 pg/mL
Interval -291.0 to 38.0
|
69 pg/mL
Interval 1.0 to 352.0
|
|
Change in Plasma Renin Levels
Baseline Minus Shock Resolution
|
-6 pg/mL
Interval -101.0 to 372.0
|
26 pg/mL
Interval 13.0 to 340.0
|
|
Change in Plasma Renin Levels
Baseline Minus 3-Hour
|
—
|
41 pg/mL
Interval 1.0 to 292.0
|
SECONDARY outcome
Timeframe: Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)Population: Number analyzed in one or more rows may be different from overall number due to participant death which would preclude subsequent measurements. 3-hour sample was done only in the angiotensin II arm.
Cystatin C will be measured from blood collected at baseline, 24 hours, and at shock resolution.
Outcome measures
| Measure |
Standard of Care Cohort
n=10 Participants
Patients in this group will receive standard of care treatment.
Standard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
|
Angiotensin II Cohort
n=18 Participants
Patients in this group will receive angiotensin II.
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 Cystatin C
Baseline Minus 24-Hour
|
-254 ng/mL
Interval -731.0 to 932.0
|
-143 ng/mL
Interval -762.0 to 121.0
|
|
Change in Plasma Cystatin C
Baseline Minus Shock Resolution
|
99 ng/mL
Interval -920.0 to 815.0
|
-124 ng/mL
Interval -524.0 to 644.0
|
|
Change in Plasma Cystatin C
Baseline Minus 3-Hour
|
—
|
-196 ng/mL
Interval -527.0 to 329.0
|
SECONDARY outcome
Timeframe: Until shock resolution, up to 14 daysDays from enrollment to discontinuation of catecholamines
Outcome measures
| Measure |
Standard of Care Cohort
n=10 Participants
Patients in this group will receive standard of care treatment.
Standard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
|
Angiotensin II Cohort
n=18 Participants
Patients in this group will receive angiotensin II.
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.
|
|---|---|---|
|
Days to Discontinuation of Catecholamines
|
0.9 days
Interval 0.5 to 3.2
|
3.5 days
Interval 1.3 to 6.4
|
SECONDARY outcome
Timeframe: From enrollment to ICU discharge, up to 28 days following enrollmentNumber of days in the intensive care unit (ICU).
Outcome measures
| Measure |
Standard of Care Cohort
n=10 Participants
Patients in this group will receive standard of care treatment.
Standard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
|
Angiotensin II Cohort
n=18 Participants
Patients in this group will receive angiotensin II.
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.
|
|---|---|---|
|
ICU Length of Stay
|
4.3 days
Interval 1.0 to 8.5
|
7.2 days
Interval 3.0 to 11.5
|
SECONDARY outcome
Timeframe: Up to 3 months following enrollmentAssessment of all-cause mortality within hospital admission
Outcome measures
| Measure |
Standard of Care Cohort
n=10 Participants
Patients in this group will receive standard of care treatment.
Standard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
|
Angiotensin II Cohort
n=18 Participants
Patients in this group will receive angiotensin II.
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.
|
|---|---|---|
|
Number of Participants With In-hospital Mortality
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Within 28 days of enrollmentDays free of renal replacement therapy from enrollment up to day 28
Outcome measures
| Measure |
Standard of Care Cohort
n=10 Participants
Patients in this group will receive standard of care treatment.
Standard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
|
Angiotensin II Cohort
n=18 Participants
Patients in this group will receive angiotensin II.
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.
|
|---|---|---|
|
Renal Replacement Therapy-free Days
|
0 days
Interval 0.0 to 0.0
|
21 days
Interval 0.0 to 28.0
|
SECONDARY outcome
Timeframe: Up to 72 hours following shock resolution, no longer than 17 days from enrollmentIncidence of venous thromboembolism, arrhythmia, extremity hypoperfusion, delirium, new ischemic event, new infection
Outcome measures
| Measure |
Standard of Care Cohort
n=10 Participants
Patients in this group will receive standard of care treatment.
Standard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
|
Angiotensin II Cohort
n=18 Participants
Patients in this group will receive angiotensin II.
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.
|
|---|---|---|
|
Number of Participants Experiencing Prespecified Safety Outcomes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)Population: Number analyzed in one or more rows may be different from overall number due to participant death which would preclude subsequent measurements. 3-hour sample was only done in the angiotensin II arm.
NGAL will be measured from blood collected at baseline, 24 hours, and at shock resolution.
Outcome measures
| Measure |
Standard of Care Cohort
n=10 Participants
Patients in this group will receive standard of care treatment.
Standard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
|
Angiotensin II Cohort
n=18 Participants
Patients in this group will receive angiotensin II.
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 Neutrophil Gelatinase-associated Lipocalin (NGAL)
Baseline Minus 24-Hour
|
10 ng/mL
Interval -13.0 to 213.0
|
93 ng/mL
Interval -39.0 to 235.0
|
|
Change in Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL)
Baseline Minus Shock Resolution
|
18 ng/mL
Interval -39.0 to 819.0
|
201 ng/mL
Interval 66.0 to 421.0
|
|
Change in Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL)
Baseline Minus 3-Hour
|
—
|
-21 ng/mL
Interval -75.0 to 85.0
|
Adverse Events
Standard of Care Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Angiotensin II Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place