Please select the eligibility criteria that correspond 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: Inclusion Criteria:

To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment:

* Patient is a male or female patient presumed to be at least 18 years of age;
* Patient has a systolic blood pressure \< 90 mmHg;
* Patient has clinical evidence of acute traumatic injury;
* Infusion of study drug must start within one hour following SBP (systolic blood pressure) \< 90 mmHg

Exclusion Criteria:

A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment:

* Patient is admitted to one of the study hospitals' Emergency Department greater than six hours after injury;
* Patient has received greater than 4 liters fluid since time of injury;
* Patient is enrolled in another shock trial;
* Patient is asystolic or requires CPR (cardiopulmonary resucitation) prior to randomization;
* Female patient is pregnant by report or suspicion;
* Patient has known "Do Not Resuscitate" orders or visible/identifiable method of objection to participation (e.g., exclusion bracelet);
B: Inclusion Criteria:

* Clinical diagnosis of Septic shock
* vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

Exclusion Criteria:

* Pregnancy
* Present cardiac dysfunction
* Present or suspected acute mesenteric ischemia
C: Inclusion Criteria:

1. High-output shock
2. Cardiovascular SOFA score of \> 4
3. Cardiac Index \> 2.4 liters/min/BSA 1.73m2
4. Indwelling arterial line already present as part of standard care
5. Age \> 21 years of age
6. Signed consent form
7. Use of indwelling urinary catheter as standard care expected at least for 12 hours during the study interventions

Exclusion Criteria:

1. Patients with acute coronary syndrome
2. Patients with a known history of vasospasm
3. Patients with a history of asthma
4. Patients currently experiencing bronchospasm
5. Patients with active bleeding with an anticipated need for \> 4 units of PRBC or Hemoglobin \< 7g/dL or any other condition that would contraindicate drawing serial blood samples
D: Inclusion criteria:

* At least 18 years of age
* Suspected infection
* Two or more systemic inflammatory response syndrome (SIRS) criteria

  * Temperature \</= 36˚ C or \>/= 38˚C
  * Heart rate \>/= 90 beats per minute
  * Mechanical ventilation for acute respiratory process or respiratory rate \>/= 20 breaths per minute or PaC02 \< 32 mmHg
  * WBC \>/= 12,000/mm³ OR \</= 4,000/mm³ OR \> 10% bands
* Refractory hypotension (a systolic blood pressure \< 90 mm Hg despite an IV fluid challenge of at least 1,000 mLs over a 30 minute period) or evidence of hypoperfusion (a blood lactate concentration \>/= 4 mmol/L)

Exclusion criteria:

* Known pregnancy
* Primary diagnosis of acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, active gastrointestinal hemorrhage, seizure, drug overdose, burn or trauma
* Requirement for immediate surgery
* ANC \< 500/mm³
* CD4 \< 50/mm³
* Do-not-resuscitate status
* Advanced directives restricting implementation of the protocol
* Contraindication to central venous catheterization
* Contradiction to blood transfusion (e.g., Jehovah's Witness)
* Treating physician deems aggressive care unsuitable
* Participation in another interventional study
* Transferred from another in-hospital setting

Answer: C