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ISRCTN
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ISRCTN76733290
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial comparing 2 small volume resuscitation fluids in the critically ill
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0025157070
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Signs and Symptoms: Sepsis
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Participants - inclusion criteria
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20 patients over 18 years with severe sepsis or septic shock
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2005
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Anticipated end date
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01/12/2007
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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20
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Interventions
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No additional invasive procedures will result from participation in this study, other than currently used as our standard clinical practice. All patients will be receiving continuous infusions of analgesic and sedating agents, intubated and receiving pressure controlled ventilation of the lungs throughout the study period, PaO2 will be kept between 8and 1 kPa and PaCO2 will be maintained between 4.5 and 7.0 kPa. The lung ventilation will be pressure controlled to reach a tidal volume between 6-8 mL/kg. No changes in the ventilator setting will be made during the study period. All patients will be requiring continuous infusions of a vasopressor agent (norepinephrine). A thermistor tipped arterial catheter will be inserted into the femoral artery of appropriate patients, as indicated as part of standard current practice by a non-participating Consultant Intensivist. This catheter allows additional measurement of cardiac output by transpulmonary thermodilution and of derived variables including intrathoracic blood volume index, continuous cardiac output by pulse-contour analysis and SVV. All transducers will be positioned at the mid-axillary line and zeroed to atmospheric pressure. Patient consent or relative's assent will be sought. Following initial resuscitation period and during period of haemodynamic stability patients will be initially monitored for 15 minutes to establish baseline values.
Subsequently all eligible patients will be randomly allocated to receive either 4mls/kg of HyperHAES or Rescueflow over 5 minutes under continuous monitoring of cardiac filling pressures. The fluid bolus will be administered via distal lumen of the CVP catheter. The allocation to fluid group will be done by a non-participating pharmacist who will also hold the randomisation key. Volume resuscitation is indicated if SVV% >15% but ITBVI < 1200 mls/m2. 250 mls fluid bolus will be given over 5 mins. No changes in vasopressor therapy during period of measurement. Ventilator settings will not be altered. Any established continuous infusion of maintenance fluid or feed will continue at same set rate throughout study period. Standard biometric data will be collected for each patient along with data to calculate the Acute Physiology and Chronic Health Evaluation II score. Type and rate of inotropic infusions will also be documented. If clinical situation demands a non-participating clinician is able to withdraw patients at any time during the 2 hour study period. Once the study period has ended, standard current clinical practice will continue.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Aintree Hospitals NHS Trust (UK)
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
Nihat
Bhuiyan
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Address
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AintreeTrust
University Hospital Aintree
Lower Lane
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City/town
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Liverpool
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Zip/Postcode
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L9 7AL
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Country
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United Kingdom
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Tel
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+44 (0)151 529 2734
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Fax
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+44 (0)151 529 3700
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Email
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nihat@doctors.net.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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07/04/2011
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Date ISRCTN assigned
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30/09/2005
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