ARGIPRESSIN for Septic shock

Inclusion criteria

• {"criterion_text":"- Patients suffering from septic shock hospitalized in an intensive setting within 24 hours of clinical diagnosis\n- Capable of expressing informed consent to treatment\n- Aged over 18 years and under 80 years of age\n- Male and female\n- Norepinephrine dosage equal to or greater than 0.25 mcg/kg/min according to the patient's ideal weight (IBW)"}

Exclusion criteria

• {"criterion_text":"- Patients in the absence of consent to participate in the study and to the processing of personal and particular data\n- Patients with allergy/intolerance to the drugs used in the study\n- Pregnant patients\n- Patients who need to start renal replacement treatment within 24 hours of admission to the ICU for dialysis emergencies that cannot be deferred\n- Patients with a history of end-stage renal failure or already undergoing dialysis treatment (CKD stages 4 and 5, with glomerular filtration < 30 ml/min)\n- Norepinephrine dosage equal to or greater than 0.5 mcg/kg/min according to the patient's ideal weight (IBW) at enrollment time\n- Single kidney patients\n- Patients with bilateral renal hypoplasia\n- Patients undergoing kidney transplant\n- Patients undergoing haemoperfusion with an adsorbent cartridge for bacterial endotoxin\n- Patients under 18 years of age or over 80 years of age\n- Patients who died within the first 24 hours of admission to the ICU\n- Patients requiring a norepinephrine dosage lower than 0.25 mcg/kg/min in the first 24 hours of hospitalization in the ICU\n- Patients with recent acute coronary syndrome (within the previous 7 days)"}

Primary endpoints

• {"endpoint_text":"- 30% reduction of patients satisfying the criteria for CRRT within the study group.","definition_or_measurement_approach":"Measured as the proportion of patients meeting criteria for continuous renal replacement therapy (CRRT) within the study group; related to use of renal replacement techniques in the first 7 days of ICU hospitalization as described in the primary objective."}

Secondary endpoints

• {"endpoint_text":"- Reduction of maximum KDIGO class reached in the first 7 days of hospitalization","definition_or_measurement_approach":"Maximum KDIGO class achieved and its evolution during the first 7 days of ICU hospitalization."}
• {"endpoint_text":"- Evaluation of renal perfusion using the CEUS method carried out within 24 hours of enrollment and 72 hours after the first evaluation (in terms of the presence of ischemic areas, their number and size","definition_or_measurement_approach":"Renal perfusion assessed sonographically using CEUS within 24 hours of enrollment and again 72 hours after first evaluation; measured by presence, number and size of ischemic areas."}
• {"endpoint_text":"- Water balance 24, 48, 72 hours after admission to the ICU","definition_or_measurement_approach":"Net fluid balance measured at 24, 48 and 72 hours after ICU admission."}
• {"endpoint_text":"- Number of patients meeting criteria for RRT during ICU stay","definition_or_measurement_approach":"Count of patients who meet criteria for renal replacement therapy during ICU admission (entire ICU stay)."}
• {"endpoint_text":"- Number of patients who develop AF, atrial flutter or PSVT lasting more than 30 minutes and who require the introduction of new drugs for rate or rhythm control or electrical cardioversion within 24 hours of arrhythmic onset","definition_or_measurement_approach":"Count of patients developing specified supraventricular arrhythmias lasting >30 minutes and requiring new drug therapy or electrical cardioversion within 24 hours of arrhythmia onset."}
• {"endpoint_text":"- Number of patients who present intestinal ischemia or extremity ischemia during the infusion of vasoactive drugs or within 3 days after the end of the administration of the aforementioned drugs","definition_or_measurement_approach":"Count of patients with intestinal or extremity ischemia occurring during vasoactive infusion or within 3 days after stopping administration."}
• {"endpoint_text":"- Length of stay in ICU and mortality at 28 and 90 days","definition_or_measurement_approach":"ICU length of stay measured in days; all-cause mortality assessed at 28 days and 90 days."}

Italy

Earliest CTIS Part Ii Submission Date

31-01-2024

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

810

Number Of Sites

1

Number Of Participants

242

Primary sponsor

Full Name

Azienda Unita Sanitaria Locale Di Bologna

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy