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"Early detection of sepsis : a randomized clinical trial."


- candidate number4728
- NTR NumberNTR1587
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-dec-2008
- Secondary IDs08.52/08.01 METC
- Public Title"Early detection of sepsis : a randomized clinical trial."
- Scientific Title"Early detection of sepsis : a randomized clinical trial."
- ACRONYMN/A
- hypothesis“Can the use of the Protocol Watch improve the earlier detection of sepsis?” The hypothesis is that the use of the Protocol Watch improves the earlier detection of sepsis with at least 60 minutes.
- Healt Condition(s) or Problem(s) studiedSepsis, Septic shock , Screening
- Inclusion criteria1. Patients admitted between Januari 1, 2009 - March 1, 2010;
2. Adult patients admitted on the surgical intensive care unit (at least 18 years of age);
3. Patients receiving major thoracic, vascular, neuro, abdominal and urologic surgery;
4. Polytraumapatients.
- Exclusion criteria1. Patients admitted on the SICU with sepsis;
2. Expected length of SICU stay less than 48 hours.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2009
- planned closingdate30-mrt-2010
- Target number of participants450
- InterventionsThe Protocol watch (PW), designed by Philips Healthcare is a new clinical support application on the patient monitor that assists clinicians in the implementation of the SSC guidelines. Protocol watch monitors the patients for the signs and symptoms of sepsis and notifies you when SIRS/Sepsis conditions occur.
- Primary outcomeDifferences in time of detection of possible sepsis, differences in time of the first lactate level-test and differences in time of the first resuscitation bundle were registered in both groups.
- Secondary outcomeNumber of septic patients in both groups. Duration of inotropic therapy ( hours) in both groups.
Duration of mechanical ventilation ( hours) in both groups.
- TimepointsT 1 --> Differences/delays in time zero of the identification will be compared in both groups. Time zero is set on the moment of detection of possible sepsis (= 2 positive sirs criteria + infection).


T 2 --> Differences/delays in time zero of the first lactate level-test will be compared in both groups.

T 3 --> Differences/delays in time zero of the resuscitation will be compared in both groups. Time zero here is set on the start of the first sepsis bundle, namely the first gift of antibiotics after retrieving blood cultures and the simultaneously start of the fluid resuscitation.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESVirga Jesse Hospital Stadsomvaart 11 Minnekeer R.D.C, Surgical Intensive Care Unit
- CONTACT for SCIENTIFIC QUERIESVirga Jesse Hospital Stadsomvaart 11 Minnekeer R.D.C, Surgical Intensive Care Unit
- Sponsor/Initiator Virga Jesse Hospital
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summary Evidence suggests that early recognition and time-sensitive resuscitation for patients with severe sepsis and septic shock can significantly improve their outcome. To obtain this objective Protocol Watch was developed as an early warning score system. The purpose of this research was to measure the benefit of the application of this bedside tool in comparison with the standard observation and interpretation of the critical team.
- Main changes (audit trail)
- RECORD13-dec-2008 - 28-jan-2009


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