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Study SOLACE SEPSIS

ConditionsSeptic ShockIntracranial Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity Hospital Pilsen

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age criteria: 18 - 90 years

acute change in total SOFA score ≥ 2 due to infection

use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg

blood lactate level ≥ 2 mmol/L within last 24 hours

Disqualifiers

Poor transthoracic echo windows

Actual body weight > 160 kg

Hypernatremia: [Na] > 150 mEq/L

Cardiac tamponade

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sodium Lactate

    Drug

    0.5M HSL (containing 504mM of sodium and lactate)

  • 3% NaCl

    Drug

    active compartor 3% NaCl

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

haemodynamic 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

Secondary outcomes

1

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
2

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.
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Pilsen

Lead sponsor

Source ClinicalTrials.gov
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