The Effect Of Resuscitation Guided By Two Different Dynamic Parameters On Time To Normalization Of The Capillary Refill Time In Adult Patients With Septic Shock, A Randomized Controlled Prospective Study

MD ∕ 22.06.664

The aim of this study is to compare the effect of resuscitation guided by Left ventricular outflow tract-velocity time integral (LVOT-VTI) variation versus the effect of resuscitation guided by inferior vena cava (IVC) variation on time to normalization of the capillary refill time in adult patients with septic shock, amount of resuscitation fluids, rate of vasopressor and ICU length of stay.

2023-07-21

2024-07-01

2024-07-01

Recruiting

Early phase I

90

Inclusion Criteria: * adult patients ( ≥ 18 years) of either gender with septic shock according to the Sepsis-3 Exclusion Criteria: * Known history of any cardiac pathology, acute coronary syndrome, cardiac dysrhythmias (as a primary diagnosis), acute pulmonary edema or known poor systolic cardiac function (left ventricular ejection fraction \< 50%). * Body mass index ≥ 35 kg/m2 . * Concomitant acute respiratory distress syndrome) or high PEEP (\> 10 cmH2O) requirements on mechanical ventilation (MV). * Child B or C liver cirrhosis. * End-stage renal disease with or without dialysis. * Pregnancy. * Multi-organ system failure. * Active hemorrhage. * Head trauma. * Intra-abdominal hypertension (\> 15 mmHg). * Declined to consent.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Left ventricular outflow tract-velocity time integral (LVOT-VTI) resuscitation based group Inferior vena cava (IVC) diameter variation resuscitation based group', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Both participants and outcome assessors will be blinded to the groups', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

2023-11-13