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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
Protocolised Management in Sepsis (ProMISe); v1.0

Protocolised Management in Sepsis: A multicentre, randomised controlled trial of the clinical and cost-effectiveness of early goal-directed protocolised resuscitation for emerging septic shock

Specialty
CriticalCare (co-adopted by InjuriesEmergencies)
Portfolio Eligibility
Automatically eligible
ISRCTN 36307479
EudraCT
MREC N° 10/H0722/42
UKCRN ID 9820
WHO ID
Research Summary
To evaluate a resuscitation protocol, with pre-determined haemodynamic goals, compared with usual resuscitation for patients admitted to the Emergency Department with emerging Septic Shock.
Study Type Interventional
Design Type Not specified, Treatment
Disease(s) Injuries and Emergencies
All Critical care
Phase N/A
Current Status Open
Closure Date 3/31/2014
Global Sample Size 1260
Global Recruitment to Date
94%
Geographical Scope UK Multi-Centre
Lead Country England
Open to new sites Yes, within and outside lead country
Health care professionals can obtain a copy of the protocol by clicking here
Main Inclusion Criteria
1) 2 or more systemic inflammatory response syndrome (SIRS) criteria;
a) Core temperature ≤ 36 or ≥ 38°C,
b) heart rate ≥ 90 beats min,
c) respiratory rate ≥ 20 breaths min−1 (or hyperventilation indicated by PaCO2 <4.3 kPa or mechanical ventilation for an acute process),
d) white blood cell count ≤ 4 or ≥ 12 × 109/l (or the presence of > 10% immature neutrophils (bands)).
2) Known or presumed infection;
3) Refractory hypotension OR hypoperfusion;
a) Hypotension is confirmed by the presence of systolic blood pressure of <90 mmHg or mean arterial pressure of <65 mmHg despite a minimum IV fluid challenge of 1 litre fixed bolus within 60 minutes (including IV fluids administered by pre-hospital personnel)
b) Hypoperfusion is confirmed by a blood lactate concentration ≥ 4mmol/L).
4) First dose of IV antimicrobial therapy initiated prior to randomisation.
Main Exclusion Criteria
1) Age < 18 years;
2) Known pregnancy;
3) Primary diagnosis of acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia (as part of primary diagnosis), seizure, drug overdose, injury from burn or trauma;
4) Hemodynamic instability due to active GI hemorrhage;
5) Requirement for immediate surgery;
6) Known history of AIDS;
7) Do-not-resuscitate status;
8) Advanced directives restricting implementation of the protocol;
9) Contraindications to central venous catheterization;
10) Contradiction to blood transfusion (i.e. Jehovah’s Witness);
11) Attending physician deems aggressive care unsuitable;
12) Transferred from another in-hospital setting;
13) Not able to start within 1 hour of randomisation or finish within 6 hours.
Chief Investigator(s)
Prof Kathy Rowan
Further details, please contact
Funder(s) NIHR Health Technology Assessment
Sponsor(s) Intensive Care National Audit & Research Centre




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