The Effects of Bolus and Slow Fluid Infusions in Healthy Volunteers with Shock

Phase 4

Completed

• Conditions: Haemorrhagic Shock; Anaesthesiology - Anaesthetics; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12615000100594
• Lead Sponsor: Department of Anaesthesia, Austin Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-04
• Study Completion: 2015-06-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Healthy adults
2. No regular medication other than contraceptive pill
3. Normal Haemoglobin level

Exclusion Criteria

1. <18 years or > 45 years in age
2. Pregnancy or have given birth within 1 year
3. Hereditary haematological conditions (sickle cell anaemia and thalassemia) that are susceptible to anaemia
4. Recent (within 10 days) history of cold, fever, or upper or lower respiratory tract infection (this may theoretically increase risk of infection with venesected blood when it is being stored prior to re-infusion)
5. Morbid Obesity (BMI> 35 kg/m2)
6. Body Weight > 100 kg

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is: Oxygen delivery (mls/kg/min)<br><br>This is easily measured by using non-invasive technology which continuously measure cardiac output, O2 saturation and haemoglobin levels throughout the study. <br><br>Determinants of oxygen delivery will be directly measured using state of non-invasive technology (Edwards Life Science ClearSight Device). These will include: <br>1. Stroke volume index (independent of heart rate)<br>2. Haemoglobin concentrations<br>3. Blood arterial saturation <br>4. Heart rate[1.Baseline (before venesection)<br>2.Immediately post venesection <br>3.30 minute post venesetion; pre-Plasmalyte infusion<br>4.Immediately post Plasmalyte infusion <br>5.60 minutes post Plasmalyte infusion<br>6.Post reinfusion of the patients venesected blood]