Randomised controlled trial comparing 2 small volume resuscitation fluids in the critically ill

ISRCTN ISRCTN76733290
DOI https://doi.org/10.1186/ISRCTN76733290
Secondary identifying numbers N0025157070
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
07/04/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nihat Bhuiyan
Scientific

AintreeTrust
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom

Phone +44 (0)151 529 2734
Email nihat@doctors.net.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Sepsis
InterventionNo 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.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2005
Completion date01/12/2007
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants20
Key inclusion criteria20 patients over 18 years with severe sepsis or septic shock
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2005
Date of final enrolment01/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

AintreeTrust
Liverpool
L9 7AL
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Aintree Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan