Status:
WITHDRAWN
Angiotensin II vs. Vasopressin in Septic Shock
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
La Jolla Pharmaceutical Company
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This will be a randomized controlled unblinded pragmatic single-center pilot trial of the use of vasopressin vs. angiotensin II as a second-line vasopressor in patients with septic shock and persisten...
Detailed Description
Sepsis affects \>1 million Americans yearly and, when septic shock ensues, is associated with high morbidity and mortality. Though first-line norepinephrine is standard of care, there are limited pros...
Eligibility Criteria
Inclusion
- 1\. Adult patients ≥18 years-old with vasodilatory shock refractory to norepinephrine monotherapy, defined as those who require ≥0.2 mcg/kg/min to maintain a MAP between 65-70 mmHg. Patients will be screened once they require ≥0.1 mcg/kg/min of norepinephrine and, if eligible, may be consented at this point. Study drug (angiotensin II or vasopressin) will be initiated once norepinephrine dose reaches ≥0.2 mcg/kg/min for at least 30 minutes.
- 2\. Patients are required to have central venous and arterial catheters present, and they are expected to remain in place for at least the initial 72 hours of study.
- 3\. Patients are required to have an indwelling urinary catheter present, and it is expected to remain in place for at least the 72 hours of study.
- 4\. Patients must have received 20-30 mL/kg of crystalloid over the previous 24-hour period, as clinically appropriate, and no longer be fluid responsive as per UNMH protocol. By UNMH protocol, lack of fluid responsiveness is considered a failure to increase stroke volume, stroke volume index, cardiac output, or cardiac index (typically measured by non-calibrated pulse contour analysis using a FloTrac device) by at least 10% after a 500-mL crystalloid bolus or a passive leg raise. Patients for whom the treating physicians feel that 20 mL/kg of crystalloid may be clinically inappropriate can qualify for the study if the reason for withholding further IV fluids is documented.
- 5\. Patient or (in patients unable to consent) legal authorized representative (LAR) is willing and able to provide written informed consent and comply with all protocol requirements.
- 6\. Approval from the attending physician and clinical pharmacist conducting the study.
Exclusion
- 1\. Patients who are \< 18 years of age.
- 2\. Patients diagnosed with acute occlusive coronary syndrome requiring intervention and/or cardiogenic shock.
- 3\. Patients with or suspected to have abdominal aortic aneurysm or aortic dissection.
- 4\. Acute stroke.
- 5\. Patients with acute mesenteric ischemia or those with a history of mesenteric ischemia.
- 6\. Patients with known Raynaud's phenomenon, systemic sclerosis, or vasospastic disease.
- 7\. Patients on veno-arterial (VA) ECMO.
- 8\. Patients with liver failure with a Model for End-Stage Liver Disease (MELD) score of ≥30.
- 9\. Patients with burns covering \>20% of total body surface area.
- 10\. Patients with a history of asthma or COPD with active acute bronchospasm or (if not mechanically ventilated) with an acute exacerbation of their asthma/COPD requiring the use of inhaled bronchodilators.
- 11\. Patients requiring more than 500 mg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose.
- 12 Patients with an absolute neutrophil count (ANC) of \< 1,000/mm3.
- 13\. Patients with hemorrhagic shock OR active bleeding AND an anticipated need (within 48 hours of initiation of the study) for transfusion of \>4 units of packed red blood cells.
- 14\. Patients with active bleeding AND hemoglobin \< 7g/dL or any other condition that would contraindicate serial blood sampling.
- 15\. Untreated venous thromboembolism (VTE) or inability to tolerate pharmacologic VTE prophylaxis.
- 16\. Patients with a known allergy to mannitol.
- 17\. Patients with an expected survival of \<24 hours, SOFA score ≥ 16, or death deemed to be imminent or inevitable during the admission
- 18\. Either the attending physician or patient and/or substitute decision-maker are not committed to all active treatment (e.g., DNR status).
- 19\. Patients who are known to be pregnant at the time of screening. \[All women ≤50 years-old will need a negative serum pregnancy test (serum quantitative beta-hCG) to enroll.\]
- 20\. Prisoner status
- 21\. Patients who are current participating in another interventional clinical trial.
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05193370
Start Date
January 3 2022
End Date
November 30 2022
Last Update
March 15 2024
Active Locations (1)
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1
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87106