None listed
Conditions
Brief summary
Patients with sepsis have the potential to become very unwell in a rapid period. The progression from being moderately unwell to severely unwell may be due to the body’s immune system responding to the infection, rather than the infection itself. A fundamental and accepted practice in the management of patients with suspected sepsis is the administration of intravenous fluids. There is no consensus that any particular fluid is better than the other. In particular, we do not know whether any time of fluid has a beneficial effect on this immune response to infection. Hypertonic saline fluid has been shown in some animal and human studies to influence the immune response to infection. In this pilot study we will assess whether hypertonic saline has an advantage over normal saline in producing beneficial immunomodulation. If this can be shown, it will inform the design of a larger multicentre trial with clinical endpoints.
Interventions
Single intravenous bolus of 5ml/kg of hypertonic (3%) saline solution
Sponsors
Royal Perth Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Suspected or proven infection 2. Two or more SIRS criteria (HR>90/min, RR>20/min, T>38 deg C, WCC>12 (or temp<36 deg C and WCC<4)) 3. Fluid bolus indicated clinically 4. Informed consent
Exclusion criteria
1. Contraindication to volume loading (e.g. coexistent acute pulmonary oedema) 2. Severe hypotension (SBP<90) requiring immediate resuscitation 3. Plasma sodium concentration outside normal range (135-145 mEq/L) 4. Established significant metabolic acidosis (venous pH <7.25) 5. Established significant renal failure eGFR < 45 mL/min/1.73m2 6. Pregnancy 7. Age less than 16 years of age 8. Deemed for palliative/supportive care only 9. Received prehospital IV fluids >500 mL in total
Outcome results
None listed