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A Multicenter, Randomized, Double-blind, Placebo-controlled, Four-arm, Parallel-group, Dose-finding Phase 2b Study to Investigate the Safety and Efficacy of TIN816 Via a Single Intravenous Infusion in the Treatment of Participants With Sepsis-associated Acute Kidney Injury (SA-AKI)
Rochester, Minn.
The purpose of this study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).
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A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients With Endotoxemic Septic Shock (TIGRIS)
Rochester, Minn.
The purpose of this study is to compare the safety and effectiveness of the PMX cartridge (Toraymyxin) based on mortality at 28 days in patients with septic shock and endotoxemia who are treated with standard medical care plus the use of the PMX cartridge, versus patients who receive standard medical care alone.
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Blood Purification for the Treatment of Critically Ill Patients With Pathogen Associated Shock: A Multicenter, Randomized Controlled Feasibility Trial (PURIFY-RCT)
Rochester, Minn.
This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and effectiveness of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock across 15 U.S. sites. Adults (18 years old and older) admitted to the ICU with all of the following:
- Pathogen associated shock defined as:
- The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation;
- Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing.
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REstrictive versus LIberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury ( RELIEVE-AKI)
Rochester, Minn.
The objective of this study is to evaluate the feasibility of alternative Net Ultrafiltration (UFNET) rate strategies among critically ill adults with acute kidney injury (AKI) and treated with Continuous Kidney Replacement Therapy (CKRT).
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Time Motion Study- Pharmacist and Physician Workflow in Dosing and Monitoring Vancomycin
Rochester, Minn.
The purpose of this study is to define the current workflow of vancomycin management for the patient.
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Closed for Enrollment
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A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients with Catecholamine-Resistant Hypotension
Rochester, Minn.
The purpose of this study is to assess the effect of LJPC-501 (angiotensin II) on the mean arterial pressure in adult patients with catecholamine-resistant hypotension.
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Diamond AST-132 NEPHROCLEAR
Rochester, Minn.
The purpose of this study is to to collect urine samples to validate the NEPHROCLEARTM CCL14 Test in intensive care unit (ICU) patients with moderate to severe (Stage 2 or 3) acute kidney injury (AKI) as an aid in the risk assessment for developing persistent severe AKI (Stage 3 AKI lasting > 72 hours) within 48 hours of patient assessment.
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Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock (EUPHRATES)
Rochester, Minn.
To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.
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High Versus Low Bicarbonate Bath in Critically-ill Patients Receiving Continuous Renal Replacement Therapy: A Pragmatic, Randomized Control Trial
Rochester, Minn.
The purpose of this study is to investigate the effect of using high versus low bicarbonate containing replacement fluid in patients with metabolic acidosis receiving continuous renal replacement therapy (CRRT) with veno-venous hemofiltration (CVVH) for acute kidney injury (AKI) on in-hospital mortality.
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Standard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial) (STARRT-AKI)
Rochester, Minn.
The purpose of this study is to determine if, in critically ill patients with severe acute kidney injury, an earlier start of renal replacement therapy compared to standard treatment will lead to improved survival and recovery of kidney function.
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