HERACLES: Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: 7.3% NaCl (intervention) At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl NaCl by infusion pump over 60 minutes. |
Drug: Hypertonic saline
At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl by infusion pump over 60 minutes.
Other Names:
|
Active Comparator: 0.9% NaCl (comparator) At admission to the ICU patients will receive 5ml/kg body weight of 0.9% NaCl by infusion pump over 60 minutes. |
Drug: 0.9% saline
At admission to the ICU patients will receive 5ml/kg body weight of 0.9% NaCl by infusion pump over 60 minutes.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- total cumulative amount of fluids infused [daily until ICU discharge, max until postoperative day 90]
Secondary Outcome Measures
- postoperative weight gain [until postoperative day 6]
- total postoperative cumulative urinary output [daily until ICU discharge, max until postoperative day 90]
- total cumulative dose of inopressors per kg bodyweight /hour [until ICU discharge, max until postoperative day 90]
cumulation of norepinephrine and epinephrine
- time on inopressors [from ICU admission until stop of inopressors, max until postoperative day 90]
norepinephrine and/or epinephrine
- variation in renal function markers [until postoperative day 6]
renal damage maker (TIMP2-IGFB, creatinine)
- variation in acid-base homeostasis [until postoperative day 6]
pH, base excess, lactate, bicarbonate, electrolytes
- variation in immune function [until postoperative day 6]
mHLA-DR
- time on the ventilator [from ICU admission until time of extubation, maximum 90 days]
- occurence of infection [occurence of infection during the index hospitalisation or subsequent admissions due to infection upto 90 postoperative days]
- length of stay [time to ICU/hospital-discharge however long this may take, maximum 90 days]
time to ICU/hospital-discharge
- readmissions to the ICU [readmissions to the ICU within postoperative 90 days]
- mortality [until postoperative day 90]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult patients undergoing cardiac surgery for ischemic or valvular heart disease
Exclusion Criteria:
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Patients unable to give informed consent
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Patients with age <18 years
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Pregnancy or breastfeeding
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Left-ventricular ejection fraction (LVEF) < 30% preoperatively
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Preexisting renal insufficiency with an eGFR <30 ml/min/1.73m2
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Patients with postoperative circulatory support devices such as LVAD, IABP, Impella, ECMO
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Preexisting serum sodium of >145mmol/l or <135 mmol/L
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Preexisting serum chloremia >107mmol/l or < 98 mmol/L
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Systemic steroid therapy (at any dose at time of inclusion)
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Chronic liver disease (bilirubin >3 mg.dl)
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Any signs of infection or sepsis defined as clear clinical evidence for active infection or current antibiotic therapy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
Investigators
- Study Director: Joerg C Schefold, MD, Department of Intensive Care, Inselspital, Bern University Hospital, Bern, Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201706011.1