University Hospital Pilsen
Pilsen, Czech Republic, 30100, Czechia
Location status: Recruiting
Location contact
Marek Nalos
CONTACT
Miroslav Kříž, MD
CONTACT
Miroslav Kříž, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06634069
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
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Phase 2
Pilsen, Czech Republic, 30100, Czechia
Location status: Recruiting
Marek Nalos
CONTACT
Miroslav Kříž, MD
CONTACT
Miroslav Kříž, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.5M HSL (containing 504mM of sodium and lactate)
Other names: 0.5M natrii lactatis
active compartor 3% NaCl
Time frame: at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus
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
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: parameters measured within the last 24 hours prior to start of infusion and within 24 hours after the study fluid infusion.
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: 30 days after intervention
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).
Contact information is provided by the study sponsor or research team.
University Hospital Pilsen
Other
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
Acronym: MJIP1_0
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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