Volume Kinetics of Fluid Resuscitation in Early Sepsis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

About this trial

The recommended volume resuscitation for patients with early sepsis-induced hypoperfusion is at least 30 ml/kg of crystalloid administered within the first three hours. However, this standardized approach does not account for individual patient variability and lacks personalization. Additionally, the effects of administering 30 ml/kg on intercompartmental fluid shifts between the plasma and interstitial compartments remain unclear. This study aims to describe the volume kinetics of administering 30 ml/kg of Ringer's Lactate in patients with early sepsis-induced hypoperfusion within the first three hours.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

hypotension requiring norepinephrine to maintain a mean arterial blood pressure (MAP) either predefined by the clinician or at 65 mm Hg or higher and/or

a serum lactate level >2 mmol/L (18mg/dL) and/or

acute oliguria defined as urine output <0.5mL/kg/hr and/or

mottled skin and/or

Disqualifiers

Administration of at least 1 L of IV fluid in the last 6 hours prior to screening. All crystalloids, colloids and blood products that the patient has received are counted.

Known pregnancy.

Competing causes of lactic acidosis including: seizures within 3 hours of enrollment, use of linezolid or metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders.

End-stage renal disease that requires chronic dialysis.

Trial population

Adult patients admitted in the intensive care unit (ICU) with sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ringer's Lactate

    Drug

    Ringer's Lactate is administered at a dose of 30ml/kg, with the first 20ml/kg given at a constant rate over the initial 30 minutes, followed by a 30-minute pause, and then an additional 10ml/kg over the next 15 minutes, completing the infusion within 75 minutes.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Ringer's Lactate1 intervention

Trial outcomes

Primary outcomes

1

Plasma Volume

Plasma volume (ml) was determined using a three-compartment kinetic model with five rate constants (k12, k21, k23, k32 and k10) and a scaling factor (Vc, central volume) that relates dilution to volume. This model was applied to the dependent variables, which included frequently measured plasma dilution and urinary excretion.

Time frame
180 minutes after the start of the Ringer's Lactate infusion

Secondary outcomes

Other outcomes

Sponsors and contacts

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