Randomised controlled trial comparing 2 small volume resuscitation fluids in the critically ill
| ISRCTN | ISRCTN76733290 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76733290 |
| Protocol serial number | N0025157070 |
| Sponsor | Department of Health |
| Funders | Aintree Hospitals NHS Trust (UK), NHS R&D Support Funding |
- 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
Scientific
AintreeTrust
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom
| Phone | +44 (0)151 529 2734 |
|---|---|
| nihat@doctors.net.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2007 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | 20 patients over 18 years with severe sepsis or septic shock |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
AintreeTrust
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
