A pilot trial of a hypertonic saline bolus in early sepsis

Phase 2

Completed

• Conditions: Sepsis; Infection - Other infectious diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12611001021965
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-23
• Study Completion: 2015-05-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circulating levels of interleukin-1 (used as an indicative inflammatory cytokine) compared to baseline level before fluid bolus. 3.5 mL serum tubes are collected from the patients at the requisite timepoints, allowed to stand at room temperature for 30 minutes to clot then centrifuged at 800g for 10 minutes at 4 deg C. Serum and plasma samples are aliquotted, stored immediately at -80 deg C and subsequently analysed using ELISA.[1, 3 and 24 hours after fluid bolus]

Secondary Outcome Measures

Name	Time	Method
Inflammatory gene activation and expression measured using qPCR compared to baseline level before fluid bolus. At the requisite timepoints 2.5mL PAXGene tubes are collected. The PAXgene tube is placed immediately at 4 deg C before being transferred to -20 deg C with 72 hours, and then transferred to -80 deg C for long-term storage and subsequent qPCR analysis.[1, 3 and 24 hours after fluid bolus];Bacterial load compared to baseline level before fluid bolus. Bacterial load is measured from PAXGene tubes as above.[1, 3 and 24 hours after fluid bolus];Haemodynamic parameters (e.g. mean arterial pressure, systolic pressure, heart rate measured non-invasively using standard equipment) compared to baseline level before fluid bolus[1, 3 and 24 hours after fluid bolus];Mortality measured by review of medical records and, where necessary, telephone follow up[28 days from enrolment]