Cardiovascular Diseases, Valvular Heart Disease
Conditions
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.
Interventions
DRUGHypertonic saline
At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl by infusion pump over 60 minutes.
DRUG0.9% saline
At admission to the ICU patients will receive 5ml/kg body weight of 0.9% NaCl by infusion pump over 60 minutes.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blind
Intervention model description
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 be performed with Ringer's lactate to normalize peripheral perfusion and to allow weaning of vasopressors.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing cardiac surgery for ischemic or valvular heart disease
Exclusion criteria
* Patients unable to give informed consent * Patients with age \<18 years * Pregnancy or breastfeeding * Left-ventricular ejection fraction (LVEF) \< 30% preoperatively * Preexisting renal insufficiency with an eGFR \<30 ml/min/1.73m2 * Patients with postoperative circulatory support devices such as LVAD, IABP, Impella, ECMO * Preexisting serum sodium of \>145mmol/l or \<135 mmol/L * Preexisting serum chloremia \>107mmol/l or \< 98 mmol/L * Systemic steroid therapy (at any dose at time of inclusion) * Chronic liver disease (bilirubin \>3 mg.dl) * Any signs of infection or sepsis defined as clear clinical evidence for active infection or current antibiotic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total cumulative amount of fluids infused | daily until ICU discharge, max until postoperative day 90 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| postoperative weight gain | until postoperative day 6 | — |
| 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 | — |
| variation in immune function | until postoperative day 6 | mHLA-DR |
Countries
Switzerland
Outcome results
None listed