* By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation in critically ill. * High molecular weight HES may, however, cause acute kidney failure in patients with severe sepsis. * Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICU) and 1st choice fluid for patients with severe sepsis. * HES 130/0.4 is largely unstudied in ICU patients. * This investigator-initiated Scandinavian multicentre trial will be conducted to assess the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis. * The trial will provide important data to all clinicians who resuscitate septic patients.
Fluid is the mainstay treatment in sepsis resuscitation, but the effects of different crystalloid and colloid solutions on outcome remain unknown. Previously, a high molecular weight hydroxyethyl starch, HES 200, was used, but this was found to cause acute kidney failure in patients with severe sepsis. As kidney failure is an independent risk factor for death in these patients, HES 200 is not used anymore. In stead a lower molecular weight starch, HES 130, has been developed. Presently, this is the preferred colloid in Scandinavian intensive care units (ICU), but the effects of HES 130 in ICU patients are currently unknown. The proposed Scandinavian multicentre study will be conducted to assess if HES 130 contributes to acute kidney failure in patients with severe sepsis. As HES 130 is widely used, the trial will provide important safety data to clinicians who resuscitate septic patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
804
Infusion for volume expansion in the ICU
Infusion for volume expansion in the ICU
Bispebjerg Hospital
Copenhagen, Denmark
Gentofte Hosptial
Copenhagen, Denmark
Glostrup Hospital
Copenhagen, Denmark
Herlev Hospital
Copenhagen, Denmark
Hvidovre Hospital
Copenhagen, Denmark
Rigshospitalet
Copenhagen, Denmark
Esbjerg Hospital
Esbjerg, Denmark
Herning Hospital
Herning, Denmark
Hillerød Hospital
Hillerød, Denmark
Hjørring Hospital
Hjørring, Denmark
...and 16 more locations
Mortality or dialysis-dependency
Time frame: 90 days
Mortality
Time frame: 28 days
Mortality
Time frame: 6 months
Mortality
Time frame: 1 year
Severity organ failure assessment score
Excluding Glascow coma score
Time frame: Day 5
Days free of ventilation
Among survivors
Time frame: 90 days
Days free of dialysis
Among survivors
Time frame: 90 days
Serious adverse reactions
Severe bleeding or severe allergic reactions
Time frame: Followed up until ICU discharge; consequently the time frame will vary among patients
Need of dialysis/haemofiltration
Time frame: Within 90 days
Need of ventilation
Time frame: Within 90 days
Kidney failure
Severity organ failure assessment score \> 2 in the renal component
Time frame: Followed up until ICU discharge; consequently the time frame will vary among patients
Hospital length of stay
Time frame: 90 days
Coagulation analyses
At selected hospitals whole-blood and biochemical coagulation analyses constitute additional secondary endpoints
Time frame: 5 days
NGAL
At selected trial sites will plasma and urinary NGAL be analysed at randomisation to assess the predictive value for dialyse and kidney failure
Time frame: 5 days
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