The Effects of Bolus and Slow Fluid Infusions in Healthy Volunteers with Shock
The Effects of a Bolus or Slow Intravenous Crystalloid Fluid Infusion on Oxygen Delivery in Healthy Volunteers with Compensated Shock
Department of Anaesthesia, Austin Hospital
9 participants
Feb 16, 2015
Interventional
Conditions
Summary
Numerous animal studies have shown that bolus or fast fluid infusion increases blood loss and mortality compared to a slow fluid infusion. Consistently, a high quality human randomised controlled trial also demonstrated that rapid crystalloid infusion increased mortality and complications in children with severe infections compared to those who received no bolus infusion. To date, no human studies have explored the effects of bolus fluid infusions and the duration of these effects on haemodynamic changes, biochemical, immunological and hormonal responses compared to those effects induced by slow infusions. This study is the first human randomised controlled trial to investigate the effects of bolus (fast) and slow infusion of crystalloid (clear) fluids in healthy volunteers. Participants will be randomly assigned to either a bolus (fast) infusion or a slow infusion group. The controlled venesection (removal) of 10 ml/kg Ideal Body Weight of blood will be conducted over a 15 minute period. Following that and after 30 minutes, participants will be resuscitated with 13 ml/kg of a either a bolus (fast) infusion (10 minutes), or a slow infusion (30 minutes) with a balanced crystalloid solution. After a 60-minute measurement period, the participants’ blood will be re-infused over a further 30-minute period. After 2 weeks, the participants will be crossed over to the other arm. Primary end point: Oxygen delivery, which can easily be measured by using a validated non-invasive haemodynamic monitor (Edwards Life Science ClearSight Device), a device that is used routinely as standard of care at Austin Health. Secondary endpoints: The effects of the rate of fluid resuscitation on mean arterial pressure, systemic vascular resistance, vascular reactivity index, biochemical, immunological and hormonal responses will also be investigated in similar timeline. Study Hypothesis: A slow crystalloid infusion has a more beneficial effect on oxygen delivery than a bolus (fast) crystalloid infusion in healthy volunteers (age 18 to 45 years) with induced compensated shock. No of participants: 9 Setting: A single centre University teaching hospital. Safety: Detailed and stringent safety guidelines will be followed in accordance with advice from the Department of Haematology at Austin Hospital, Austin Hospital Blood Bank, Victorian Red Cross, and the Department’s of Anaesthesia and ICU. Each experiment will conducted by a senior anaesthetist, in a theatre environment, with the appropriate monitoring and safety equipment to effectively and safely conduct this study. Clinical significance: These results will used to generate hypotheses and establish outcome benchmarks for future controlled trials that will directly influence how patients with haemorrhagic shock are optimally resuscitated.
Eligibility
Inclusion Criteria3
- Healthy adults
- No regular medication other than contraceptive pill
- Normal Haemoglobin level
Exclusion Criteria6
- <18 years or > 45 years in age
- Pregnancy or have given birth within 1 year
- Hereditary haematological conditions (sickle cell anaemia and thalassemia) that are susceptible to anaemia
- 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)
- Morbid Obesity (BMI> 35 kg/m2)
- Body Weight > 100 kg
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Interventions
After the venesection of 10 ml/kg Ideal Body Weight of blood over a 15 minute period from healthy fit adult subjects, participants will be randomised to receive a intravenous crystalloid fluid (Plasma-Lyte 148) for resuscitation. The type of fluid used is Plasma-Lyte 148 solution (Baxter Healthcare). The amount of Plasma-Lyte 148 solution that will be administered is 13 ml/kg (Ideal Body Weight) . Plasma-Lyte 148 solution will be infused continuously via the intravenous route through a peripheral intravenous cannula. The Plasma-Lyte 148 infusion will commence exactly 15 minutes after completion of the venesection. Plasma-Lyte 148 solution will infused over 2 time periods/arms depending on randomisation. 1. Over a 10 minutes period (Bolus infusion group) 2. Over a 30 minutes period (Slow infusion group) The ratio of 1:1.3 ratio of the volume of blood to the volume of Plasmalyte is adopted from the landmark clinical trial, The Saline versus Albumin Fluid Evaluation Study (SAFE). Once the Plasma-Lyte 148 solution has been infused, data collection will be conducted for 60 minutes. Once data collection is completed, the venesected blood will be re-infused back to the participant over a 30 minute period. The study will then be concluded. Participants will then be crossed over to the other infusion period/arm between 7 -14 days later i.e there will be a washout period of between 7-14 days between the 2 interventions.
Locations(1)
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ACTRN12615000100594