Trial · NCT01393782
Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study
NCT01393782, Phase 1, Completed, George Washington University; results first posted 2024-04-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study. Trials, record NCT01393782. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01393782
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study
- NCT number
- NCT01393782
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- George Washington University
- Conditions
- Septic Shock
- Interventions
- Angiotensin II
- First posted
- 2011-07-13
- Last updated
- 2024-04-12
- Results first posted
- 2024-04-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Standing Dose of Norepinephrine Which is Required to Maintain a Mean Arterial Pressure (MAP) of 65 mmHg - Hour 1 | 1 hour after initiation of angiotensin II (ATII) | The primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a mean arterial pressure (MAP) of 65 mmHg. |
| Primary | Standing Dose of Norepinephrine Which is Required to Maintain a MAP of 65 mmHg - Hour 2 | 2 hours after initiation of ATII | The primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a MAP of 65 mmHg. |
| Secondary | Mortality | 30 days | 30 day post dose mortality will be assessed. Subjects discharged prior to day 30 will be contacted by telephone for this assessment. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Standing Dose of Norepinephrine Which is Required to Maintain a Mean Arterial Pressure (MAP) of 65 mmHg - Hour 1 | 1 hour after initiation of angiotensin II (ATII) | mcg/min | MEAN | |
| PRIMARY | Standing Dose of Norepinephrine Which is Required to Maintain a MAP of 65 mmHg - Hour 2 | 2 hours after initiation of ATII | mcg/min | MEAN | |
| SECONDARY | Mortality | 30 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Standing Dose of Norepinephrine Which is Required to Maintain a Mean Arterial Pressure (MAP) of 65 mmHg - Hour 1 | Angiotensin | 7.4 | Standard Deviation 12.4 | mcg/min | |
| Standing Dose of Norepinephrine Which is Required to Maintain a Mean Arterial Pressure (MAP) of 65 mmHg - Hour 1 | Control | 27.6 | Standard Deviation 29.3 | mcg/min | |
| Standing Dose of Norepinephrine Which is Required to Maintain a MAP of 65 mmHg - Hour 2 | Angiotensin | 7.3 | Standard Deviation 11.9 | mcg/min | |
| Standing Dose of Norepinephrine Which is Required to Maintain a MAP of 65 mmHg - Hour 2 | Control | 28.6 | Standard Deviation 30.2 | mcg/min | |
| Mortality | Angiotensin | 5 | Participants | ||
| Mortality | Control | 6 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Angiotensin | 10 | |
| Overall Study | STARTED | Control | 10 | |
| Overall Study | COMPLETED | Angiotensin | 10 | |
| Overall Study | COMPLETED | Control | 10 | |
| Overall Study | NOT COMPLETED | Angiotensin | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypertension | Cardiac disorders | Angiotensin | 2 | 10 | |
| other | Hypertension | Cardiac disorders | Control | 0 | 10 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Angiotensin | 5 | 10 |
| Total, all-cause mortality | Control | 6 | 10 |
| Total, other adverse events | Angiotensin | 2 | 10 |
| Total, other adverse events | Control | 0 | 10 |
| Total, serious adverse events | Angiotensin | 0 | 10 |
| Total, serious adverse events | Control | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25286986 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Angiotensin vs Control: Mortality | Trial comparisons |
| Angiotensin vs Control: deaths from any cause | Trial comparisons |
| Angiotensin vs Control: 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/NCT01393782
GET https://conductscience.org/api/trials/v1/NCT01393782/registered