Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study
Brief 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.


Options:
A: Arm Label: I; Type: EXPERIMENTAL; Interventions: Drug: vasopressin | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: normal saline control | Intervention Type: DRUG; Name: normal saline control; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: vasopressin; Assigned to Arm(s): I
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Terlipressin | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Vasopressin | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Norepinephrine | Intervention Type: DRUG; Name: Terlipressin; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Vasopressin; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Norepinephrine; Assigned to Arm(s): 3
C: Arm Label: Angiotensin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Angiotensin II | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Drug: Angiotensin II | Intervention Type: DRUG; Name: Angiotensin II; Assigned to Arm(s): Angiotensin, Control
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Procedure: Early Goal Directed Therapy (EGDT) | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Procedure: Protocolized Standard Care (PSC) | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Usual Care (UC) | Intervention Type: PROCEDURE; Name: Early Goal Directed Therapy (EGDT); Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Protocolized Standard Care (PSC); Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: Usual Care (UC); Assigned to Arm(s): 3

Answer: C