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| [ Print-friendly version ] |
| The clinical and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock |
| ISRCTN | ISRCTN36307479 |
| ClinicalTrials.gov identifier | |
| Public title | The clinical and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock |
| Scientific title | A multicentre, randomised controlled trial of the clinical and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock |
| Acronym | ProMISe |
| Serial number at source | HTA 07/37/47; ICNARC/01/01/09 |
| Study hypothesis | To evaluate a resuscitation strategy with pre-determined haemodynamic endpoints compared to usual care for patients with severe sepsis or septic shock. |
| Ethics approval | Not provided at time of registration |
| Study design | Prospective multicentre randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Severe sepsis/septic shock |
| Participants - inclusion criteria |
1. Greater than or equal to 18 years of age, either sex
2. Known or presumed infection 3. Two or more systemic inflammatory response syndrome (SIRS) criteria: 3.1. Core temperature less than or equal to 36°C or greater than or equal to 38°C 3.2. Heart rate greater than or equal to 90 beats/min 3.3. Respiratory rate greater than or equal to 20 breaths/min (or hyperventilation indicated by partial pressure of carbon dioxide in arterial blood [PaCO2] 4.3 kPa or mechanical ventilation for an acute process) 3.4. White blood cell count less than or equal to 4 x 10^9 l or greater than or equal to 12 x 10^9 l (or the presence of greater than 10% immature neutrophils "bands") 4. Refractory hypotension or hypoperfusion: 4.1. Hypotension is confirmed by the presence of systolic blood pressure less than 90 mmHg despite an intravenous (IV) fluid challenge of at least 20 ml/kg within 30 minutes of Emergency Department (ED) arrival (including IV fluids administered by pre-hospital/Emergency Medical Services [EMS] personnel) 4.2. Hypoperfusion is confirmed by a blood lactate concentration greater than or equal to 4 mmol/L) 5. First dose of IV antimicrobial therapy commenced prior to randomisation |
| Participants - exclusion criteria |
1. Aged less than 18 years
2. Known pregnancy 3. Primary diagnosis of acute cerebral vascular event, acute coronary syndrome, acute pulmonary oedema, status asthmaticus, major cardiac arrhythmia (as part of primary diagnosis), seizure, drug overdose, injury from burn or trauma 4. Haemodynamic instability due to active gastrointestinal (GI) haemorrhage 5. Immunosuppressive agents including chemotherapy for uncured cancer, immunosuppression for organ transplantation or from systematic disease 6. Requirement for immediate surgery 7. Do not resuscitate status 8. Advanced directives restricting implementation of the protocol 9. Contraindications to central venous catheterisation 10. Contradiction to blood transfusion (i.e. Jehovah's Witness) 11. Attending physician deems aggressive care unsuitable 12. Participation in another interventional study 13. Transferred from another in-hospital setting 14. Not able to start within 1 hour of randomisation or finish within 6 hours |
| Anticipated start date | 01/06/2010 |
| Anticipated end date | 31/07/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 1260 |
| Interventions |
Intervention arm: Early goal-directed protocolised resuscitation; targeting of specific haemodynamic goals including central venous pressure, mean arterial pressure and central venous oxygen saturation.
Control arm: Usual care Patients admitted to Emergency Departments with severe sepsis or septic shock will undergo 6 hours of the intervention arm post-randomisation. For the control arm patients will be treated via usual care for these 6 hours. After this patients will be treated with standard care. Patients will be followed up for a year post-admission to hospital. This will include assessments at 28 days, 90 days and 1 year. This trial is not classed as a CTIMP. |
| Primary outcome measure(s) |
1. To estimate the effect of early, goal-directed, protocolised resuscitation compared with usual care on mortality at 90-days
2. To compare the incremental cost-effectiveness, at one year, of early, goal-directed, protocolised resuscitation versus usual care |
| Secondary outcome measure(s) |
1. Duration of survival
2. Mortality at 28 days 3. Mortality at discharge from critical care and discharge from hospital 4. Mortality at one year 5. Sequential Organ Failure Assessment (SOFA) score at 6 hours and 72 hours (adjusted for baseline) 6. Requirement for, and duration of, monitoring and support of specific organ systems (CCMDS) 7. Duration of ED, critical care unit and hospital stay 8. Health-related quality of life (EQ-5D) at 90 days and one year 9. Resource use and costs at 90 days and one year 10. Lifetime incremental cost-effectiveness |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Kathryn Rowan |
| Address |
Intensive Care National Audit and Research Centre (ICNARC)
Tavistock House Tavistock Square |
| City/town | London |
| Zip/Postcode | WC1H 9HR |
| Country | United Kingdom |
| kathy.rowan@icnarc.org | |
| Sponsor | Intensive Care National Audit and Research Centre (ICNARC) (UK) |
| Address |
c/o Keryn Vella
Tavistock House Tavistock Square |
| City/town | London |
| Zip/Postcode | WC1H 9HR |
| Country | United Kingdom |
| Sponsor website: | https://www.icnarc.org/ |
| Date applied | 18/11/2009 |
| Last edited | 19/11/2009 |
| Date ISRCTN assigned | 19/11/2009 |
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| © 2010 ISRCTN unless otherwise stated. | |
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