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Recruiting NCT06634069

Study SOLACE SEPSIS

Phase II Interventional Septic Shock Intracranial Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sodium Lactate, 3% NaCl.
Who it may be relevant to
Registry conditions: Septic Shock, Intracranial Hypertension. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

  • Drug Sodium Lactate
    0.5M HSL (containing 504mM of sodium and lactate)
  • Drug 3% NaCl
    active compartor 3% NaCl

Primary outcome measures

  • haemodynamic effects [Time frame: at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus]
Secondary outcome measures (3)
  • acid-base effect [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 [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 [Time frame: 30 days after intervention]

Eligibility criteria

Inclusion criteria

  • Subjects will be eligible for the trial if they meet all of the following criteria:
  • Age criteria: 18 - 90 years
  • Septic shock - Sepsis 3 criteria :
  • 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
  • Likely need for fluid resuscitation
  • poor peripheral perfusion as evidenced by 2 out of 4: i. peripheral cyanosis with delayed capillary refill ≥ 3 seconds ii. low urinary output (< 0.5 ml/kg/hour for at least 6 hours) iii. central venous O2 saturation < 70% iv. clouded sensorium/poor mentation
  • dynamic assessment of preload responsiveness as evidenced by 1 out of 3: i. positive passive leg raising test ii. pulse pressure variation and / or stroke volume variation2, both > 12% iii. distensibility index of inferior vena caval diameter > 12%
  • Signed the relevant informed consent form

Exclusion criteria

  • Subjects will not be eligible for the trial if they meet any of the following criteria:
  • Poor transthoracic echo windows
  • Actual body weight > 160 kg
  • Hypernatremia: \[Na\] > 150 mEq/L
  • Cardiac tamponade
  • Uncorrected severe valvular heart disease or life-threatening arrhythmia
  • Moribund patients likely to die before the study protocol is completed
  • Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH < 7.0, K > 7.0mmol/L
  • Severe liver dysfunction defined by total serum bilirubin > 120 umol/l
  • Pregnancy and lactation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • University Hospital Pilsen — Pilsen

Identifiers

NCT: NCT06634069 · EU CTR: 2024-517927-37-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗