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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01393782
The ClinicalTrials.gov registry entry for NCT01393782 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,058-participant average among 24 other Septic Shock trials with a reported enrollment target (100% lower). The listed sponsor is George Washington University, which has 133 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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