Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01393782 · ClinicalTrials.gov registry record · Phase 1
Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study
A Phase 1 study of Septic Shock, sponsored by George Washington University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01393782: Completed Phase 1 study of Septic Shock, sponsored by George Washington University.
NCT01393782 is a Phase 1 study of Septic Shock that has completed, run by George Washington University. The registered enrollment target is 20 participants, below the 5,058-participant average among 24 other Septic Shock trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01393782, a Phase 1 study of Septic Shock, has completed, sponsored by George Washington University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose a dose finding study to determine the feasibility of Angiotensin II (AII) to increase mean arterial pressure in high-output shock. If AII can be shown to increase mean arterial pressure, this could lead to future pharmacologic development based on the AII hormonal pathway. The investigators propose a 20 patient, randomized, placebo-controlled, blinded study in the treatment of high-output shock. Patients with high-output shock and a cardiovascular SOFA (sequential organ failure score) score of \> 4 will be eligible. In addition, patients must already be receiving cardiac output monitoring and have a cardiac index \> 2.4 L/min/ 1.73 m2. Patients will be randomized to intravenous AII or saline in a blinded fashion. There will be 10 patients in each arm. This is a safety and dose finding feasibility study. The investigators are starting with a small cohort consistent with similar types of studies. The investigators estimate that ten patients in each arm will generate a basis for determining if there is sufficient signal for AII to improve blood pressure at the doses outlined. 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. Secondary endpoints will be the effect of AII on urine output, serum lactate, and creatinine clearance. 30 day post dose mortality will also be assessed. Subjects discharged prior to day 30 will be contacted by telephone for this assessment.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Angiotensin II
Study Locations (1)
District of Columbia
- GW University - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT01393782 record still lists
NCT01393782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 5,058-participant average among 24 other Septic Shock trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Septic Shock appearing as the primary indexed condition, and to 1 intervention - of which Angiotensin II is the first listed.
NCT01393782 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01393782 about?
NCT01393782 is a clinical study titled "Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study". The investigators propose a dose finding study to determine the feasibility of Angiotensin II (AII) to increase mean arterial pressure in high-output shock. If AII can be shown to increase mean arterial pressure, this could lead to future pharmacologic development based on the AII hormonal pathway. ...
What is the current status of trial NCT01393782?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-07. Estimated completion is 2014-01.
What conditions does trial NCT01393782 study?
This clinical trial studies the following conditions: Septic Shock.
What interventions are being tested in trial NCT01393782?
The interventions under investigation include: Angiotensin II (DRUG).
Who is sponsoring clinical trial NCT01393782?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01393782 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Septic Shock
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01393782's enrollment target sits among peer trials
20 21st of 24 higher than 3 of 24 other Septic Shock trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Septic Shock trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Stress Hydrocortisone In Pediatric Septic Shock
RECRUITING · Phase 3
-
Early Versus Late Adjunctive Vasopressin in Septic Shock
RECRUITING · Phase 4
-
External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
RECRUITING · NA
-
A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
RECRUITING · Phase 3
-
Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis
RECRUITING · NA
-
Assessment for Implementation Methods in Sepsis
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia