A Pilot, Randomized, Double-Blinded, Controlled Study of Hemodynamic and Acid Base Effects of 0.5M Sodium Lactate and 3% Saline Solutions in Septic Shock Patients
This study investigates two resuscitation fluids that are being used off label for the treatment of patients suffering from septic shock and also in patients with intracranial hypertension in intensive care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
0.5M HSL (containing 504mM of sodium and lactate)
active compartor 3% NaCl
University Hospital Pilsen
Pilsen, Czech Republic, Czechia
RECRUITINGhaemodynamic effects
SV is the amount of blood that leaves the left ventricle with every beat cycle and is calculated by measuring the Doppler flow in the aortic valve. Unit: ml
Time frame: at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus
acid-base effect
Diagnostic approach to acid-base changes is based on the assessment of bicarbonate buffer system, in which pH is determined by the ratio of \[HCO3-\] to pCO2 meassured by a POC whole-blood analyzer system Unit: \[HCO3-\] - mmol/l, pCO2 - kPa
Time frame: at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus
anti-inflammatory effect
Inflammatory markers as CRP, procalcitonin, interleukin-6 and feritin are sepcific indicators linked to degree of inflammation and determined by regular biochemical analysis. The dynamics of parameters after the study fluid administration will be evaluated. Unit: CRP - mg/l, procalcitonin - ug/l, interleukin-6 - ng/l, ferritin - ug/l
Time frame: parameters measured within the last 24 hours prior to start of infusion and within 24 hours after the study fluid infusion.
Safety - Incidence of adverse events and reactions
Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) and descriptive analysis of the incidence of any adverse events and reactions during participation in the study in both study arms. AEs are defined according to the valid definitions for clinical trials as imposed by legislation (Directive 2001/20/EG).
Time frame: 30 days after intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.