Septic Shock Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo university hospitals, kasralainy | Cairo | |
Egypt | Mansoura University, Central Hospital | Mansoura | Dakahlia |
Lead Sponsor | Collaborator |
---|---|
Kasr El Aini Hospital | Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to normalization of the capillary refill time (= 3 sec) | Time to normalization of the capillary refill time (= 3 sec.) in adult patients with septic shock at 6h of septic shock recognition in patients with delayed capillary refill time (> 3 sec.) | 12 hours | |
Secondary | Amount of resuscitation fluids | total amount of lactated ringer crystalloid solution resuscitation | 24 hours | |
Secondary | Total amount of vasopressors. | Total amount of vasopressors. | 24 hours | |
Secondary | Change in Creatinine-based Kidney Disease: Improving Global Outcome (KDIGO) score | Change in Creatinine-based Kidney Disease: Improving Global Outcome (KDIGO) score from baseline KDIGO score:Stage 1 Serum creatinine 1.5-1.9 times baseline or =0.3 mg/dl (=26.5 mmol/l) increase or Urine output <0.5 ml/kg/h for 6-12 hours
Stage 2 Serum creatinine 2.0-2.9 times baseline or <0.5 ml/kg/h for =12 hours Stage 3 Serum creatinine 3.0 times baseline or Increase in serum creatinine to =4.0 mg/dl (=353.6 mmol/l) or Initiation of renal replacement therapy or in patients <18 years, decrease in eGFR to <35 ml/min per 1.73 m² or Urine output <0.3 ml/kg/h for =24 hours or anuria for =12 hours |
72 hours | |
Secondary | ICU length of stay | ICU length of stay from admission to discharge from ICU. | 1 week |
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