Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland
Bern, 3010, Switzerland
NCT Number: NCT03280745
Background: Volume replacement strategies and type of fluid used in patients undergoing cardiac surgery have changed during the last years. Currently used crystalloid solutes have a variable composition and a major impact on organ function and outcome. Additionally critically ill patients are prone to fluid overload, which is despite common perception, not a benign occurrence as it is associated with prolonged ICU- and hospital length of stay and increased mortality rates. Fluid resuscitation using bolus or continuous infusion of hypertonic saline was used for more than thirty years. Only a few studies have been conducted so far, but they showed that infusion of hypertonic saline results in less volume administered, increased renal function less weight gain in critically ill patients when compared to other crystalloids.
Aim: This preliminary randomized controlled double-blind study aims to identify whether fluid resuscitation using hypertonic saline (HS) when used in addition to lactated Ringers solution results in less total fluid amount administered in patients following cardiac surgery. Additionally we want to evaluate whether the use of hypertonic saline results less need for pharmacological cardiocirculatory support, increased renal function, less postoperative volume overload shortened post-cardiac bypass immune suppression and increased postoperative outcomes.
Study intervention: At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl or 0.9% NaCl by infusion pump over 60 minutes. If necessary, fluid resuscitation will thereafter be performed with Ringer's lactate to normalize peripheral perfusion and to allow weaning of vasopressors.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Bern, 3010, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl by infusion pump over 60 minutes.
Other names: 7.9% NaCl
At admission to the ICU patients will receive 5ml/kg body weight of 0.9% NaCl by infusion pump over 60 minutes.
Other names: normal saline
Time frame: daily until ICU discharge, max until postoperative day 90
Time frame: until postoperative day 6
Time frame: daily until ICU discharge, max until postoperative day 90
Time frame: until ICU discharge, max until postoperative day 90
cumulation of norepinephrine and epinephrine
Time frame: from ICU admission until stop of inopressors, max until postoperative day 90
norepinephrine and/or epinephrine
Time frame: until postoperative day 6
renal damage maker (TIMP2-IGFB, creatinine)
Time frame: until postoperative day 6
pH, base excess, lactate, bicarbonate, electrolytes
Time frame: until postoperative day 6
mHLA-DR
Time frame: from ICU admission until time of extubation, maximum 90 days
Time frame: occurence of infection during the index hospitalisation or subsequent admissions due to infection upto 90 postoperative days
Time frame: time to ICU/hospital-discharge however long this may take, maximum 90 days
time to ICU/hospital-discharge
Time frame: readmissions to the ICU within postoperative 90 days
Time frame: until postoperative day 90
Insel Gruppe AG, University Hospital Bern
Other
Acronym: HERACLES
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