Sepsis Sepsis-
Conditions
Interventions
resuscitation using lactated Ringer’s solution (LRS) infusion in the rate of 10 ml/kg/hr (via infusion pump) for the first 30 ml/kg of fluid resuscitation. After completion of the designated fluid&#
further fluid resuscitation will be given according to the physician’s discretion,
but in the rate of not more than 10 ml/kg/hr until 6 hours.,resuscitation using lactated Ringer’s solution (LRS) infusion in the rate of 30 ml/kg/hr (via infusion pump,
with maximum rate of 2000 ml/hr) for the first 30 ml/kg of fluid resuscitation. After completion of the designated fluid,
but in the rate of not more than 30 ml/kg/hr (or maximum rate of 2000 ml/hr) until 6 hours.
Experimental Drug,Active Comparator Drug
Limited rate of fluid resuscitation,usual rate of fluid resuscitation
Sponsors
Jutamas Saoraya
Faculty of Medicine,
Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. adults aged 18 or over 2. with suspected sepsis according to the sepsis-3 definition identified by [18] a. suspected infection with b. qSOFA ≥ 2/3 i. alteration in mental status ii. Systolic Blood Pressure (SBP) ≤ 100 mmHg iii. Respiratory rate (RR) ≥ 22/min 3. and hypoperfusion as by clinician’s decision to use fluid bolus therapy for 30 ml/kg including a. Systolic Blood Pressure (SBP) < 90 mmHg, b. MAP < 65 mmHg c. lactate ≥ 2 mmol/L.
Exclusion criteria
Exclusion criteria: 1. Received resuscitation fluid for more than 500 ml. 2. Severe hypotension (SBP < 70 mmHg) 3. Suspected other main causes of hypoperfusion (obstructive, cardiogenic, hypovolemic such as gastrointestinal hemorrhage) 4. Concurrent acute heart failure or known left ventricular ejection fraction (LVEF) less than 40% or poor LVEF by eyeballing on point of care ultrasound (POCUS) 5. End stage renal disease (ESRD) with chronic RRT 6. Suspected infection from microorganisms other than bacteria 7. Potentially need for immediate surgery in 6 hours 8. Body mass index (BMI) ≥ 30 kg/m2 9. Concurrent acute traumatic brain injury 10. Do-Not-Attempt-Resuscitation (DNAR) order status 11. Transferred from another hospital 12. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of syndecan-1 level 6 hour serum syndecan-1 | — |
Secondary
| Measure | Time frame |
|---|---|
| lactate clearance 6 hour serum lactate,percentage of patients with MAP >= 65 hour 1 and hour 6 observation,P/F ratio hour 6 Arterial blood gas,all cause mortality day 28, 90 observation and telephone inquiry,Time to death 90 day observation and telephone inquiry,Hospital length of stay 28 day observation,fluid input hour 6 observation,fluid balance 24 and 72 hour observation,organ failure-free day 28 day observation,requirement for intubation, time to intubation, ventilator-free days, development of ARDS 28 day observation,requirement for new renal replaement therapy (RRT), RRT-free days 28 day observation,requirement for vasopressor, time to vasopressor initiation, duration of vasopressor 28 day observation,vasopressor-free day 28 day observation,cardiogenic pulmonary edema 6 hour observation,new arrhythmia 6 hour observation,extravasation of norepinephrine 6 hour observation,early termination of the study protocol and reasons 6 hour observation | — |
Countries
Thailand
Contacts
Public ContactJutamas Saoraya
Chulalongkorn University
Outcome results
None listed