Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
07/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nihat Bhuiyan

ORCID ID

Contact details

AintreeTrust
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom
+44 (0)151 529 2734
nihat@doctors.net.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0025157070

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Signs and Symptoms: Sepsis

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2005

Overall trial end date

01/12/2007

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

20 patients over 18 years with severe sepsis or septic shock

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2005

Recruitment end date

01/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

AintreeTrust
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Aintree Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes