CompletedPhase 4

The Effect of Restrictive Fluid Management on Cardiac Function and Glycocalyx Degradation

Sweden54 participantsStarted 2020-02-02

Plain-language summary

The study aims to compare the effects of restrictive fluid management on cardiac dysfunction and vascular integrity in septic shock patients. To achieve this, patients with septic shock according to Sepsis-3 criteria admitted to several Intensive Care Units in Sweden and Denmark will be randomized to receive restrictive respectively standard fluid therapy. Blood test from these patients will be analyzed for several biomarkers of cardiac function and glycocalyx degradation. Echocardiography will also be performed to further investigate cardiac function.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Patients with septic shock according to the Sepsis-3 criteria who have received at least 1 L of IV fluid in the 24 hours before screening Exclusion Criteria: * Patients who have had septic shock for more than 12 hours at the time of screening * Patients who have life-threatening bleeding * Patients with acute burn injury \>10% of the body surface area * Pregnant patients * Patients in whom consent cannot be obtained

What they're measuring

Myocardial injury

Timeframe: Compare result within 24 hours of enrolment with day 2-3 and day 7-10 or at discharge

Hyaluronan levels

Timeframe: First morning after enrolment (within 24 hours from enrollment)

Trial details

NCT IDNCT04282252

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-22

View on ClinicalTrials.gov More Septic Shock trials