Trial · NCT04558359
Renin and Renal Biomarker Response to Angiotensin II
NCT04558359, Phase 4, Completed, Alexander Flannery; results first posted 2024-09-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Renin and Renal Biomarker Response to Angiotensin II. Trials, record NCT04558359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04558359
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Renin and Renal Biomarker Response to Angiotensin II
- NCT number
- NCT04558359
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 30 participants, actual
- Lead sponsor
- Alexander Flannery
- Conditions
- Septic Shock, Acute Kidney Injury
- Interventions
- Standard of Care, Angiotensin II
- First posted
- 2020-09-22
- Last updated
- 2024-09-04
- Results first posted
- 2024-09-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Plasma Renin Levels | 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 | Change in Plasma Cystatin C | Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days) | Cystatin C will be measured from blood collected at baseline, 24 hours, and at shock resolution. |
| Secondary | Days to Discontinuation of Catecholamines | Until shock resolution, up to 14 days | Days from enrollment to discontinuation of catecholamines |
| Secondary | ICU Length of Stay | From enrollment to ICU discharge, up to 28 days following enrollment | Number of days in the intensive care unit (ICU). |
| Secondary | Number of Participants With In-hospital Mortality | Up to 3 months following enrollment | Assessment of all-cause mortality within hospital admission |
| Secondary | Renal Replacement Therapy-free Days | Within 28 days of enrollment | Days free of renal replacement therapy from enrollment up to day 28 |
| Secondary | Number of Participants Experiencing Prespecified Safety Outcomes | 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 |
| Secondary | Change in Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) | Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days) | NGAL will be measured from blood collected at baseline, 24 hours, and at shock resolution. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Plasma Renin Levels | Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days) | 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. | pg/mL | MEDIAN |
| SECONDARY | Change in Plasma Cystatin C | Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days) | 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. | ng/mL | MEDIAN |
| SECONDARY | Days to Discontinuation of Catecholamines | Until shock resolution, up to 14 days | days | MEDIAN | |
| SECONDARY | ICU Length of Stay | From enrollment to ICU discharge, up to 28 days following enrollment | days | MEDIAN | |
| SECONDARY | Number of Participants With In-hospital Mortality | Up to 3 months following enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Renal Replacement Therapy-free Days | Within 28 days of enrollment | days | MEDIAN | |
| SECONDARY | Number of Participants Experiencing Prespecified Safety Outcomes | Up to 72 hours following shock resolution, no longer than 17 days from enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) | Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days) | 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. | ng/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Plasma Renin Levels | Standard of Care Cohort | Baseline Minus 24-Hour Sample | -15 | Inter-Quartile Range -291 to 38 | pg/mL |
| Change in Plasma Renin Levels | Angiotensin II Cohort | Baseline Minus 24-Hour Sample | 69 | Inter-Quartile Range 1 to 352 | pg/mL |
| Change in Plasma Renin Levels | Standard of Care Cohort | Baseline Minus Shock Resolution | -6 | Inter-Quartile Range -101 to 372 | pg/mL |
| Change in Plasma Renin Levels | Angiotensin II Cohort | Baseline Minus Shock Resolution | 26 | Inter-Quartile Range 13 to 340 | pg/mL |
| Change in Plasma Renin Levels | Angiotensin II Cohort | Baseline Minus 3-Hour | 41 | Inter-Quartile Range 1 to 292 | pg/mL |
| Change in Plasma Cystatin C | Standard of Care Cohort | Baseline Minus 24-Hour | -254 | Inter-Quartile Range -731 to 932 | ng/mL |
| Change in Plasma Cystatin C | Angiotensin II Cohort | Baseline Minus 24-Hour | -143 | Inter-Quartile Range -762 to 121 | ng/mL |
| Change in Plasma Cystatin C | Standard of Care Cohort | Baseline Minus Shock Resolution | 99 | Inter-Quartile Range -920 to 815 | ng/mL |
| Change in Plasma Cystatin C | Angiotensin II Cohort | Baseline Minus Shock Resolution | -124 | Inter-Quartile Range -524 to 644 | ng/mL |
| Change in Plasma Cystatin C | Angiotensin II Cohort | Baseline Minus 3-Hour | -196 | Inter-Quartile Range -527 to 329 | ng/mL |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard of Care Cohort | 10 | |
| Overall Study | STARTED | Angiotensin II Cohort | 18 | |
| Overall Study | COMPLETED | Standard of Care Cohort | 10 | |
| Overall Study | COMPLETED | Angiotensin II Cohort | 18 | |
| Overall Study | NOT COMPLETED | Standard of Care Cohort | 0 | |
| Overall Study | NOT COMPLETED | Angiotensin II Cohort | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard of Care Cohort | 9 | 10 |
| Total, all-cause mortality | Angiotensin II Cohort | 9 | 18 |
| Total, other adverse events | Standard of Care Cohort | 0 | 10 |
| Total, other adverse events | Angiotensin II Cohort | 0 | 18 |
| Total, serious adverse events | Standard of Care Cohort | 0 | 10 |
| Total, serious adverse events | Angiotensin II Cohort | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Angiotensin II Cohort vs Standard of Care Cohort: Number of Participants With In-hospital Mortality | Trial comparisons |
| Angiotensin II Cohort vs Standard of Care Cohort: deaths from any cause | Trial comparisons |
| Angiotensin II Cohort vs Standard of Care Cohort: Number of Participants Experiencing Prespecified Safety Outcomes | Trial comparisons |
| Angiotensin II Cohort vs Standard of Care Cohort: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04558359
GET https://conductscience.org/api/trials/v1/NCT04558359/results?page=2