Clinical trial NCT03280745: Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery
Official title: Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Valvular Heart Disease
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: total cumulative amount of fluids infused
timeFrame: daily until ICU discharge, max until postoperative day 90
Secondary outcomes:
measure: postoperative weight gain
timeFrame: until postoperative day 6
measure: total postoperative cumulative urinary output
timeFrame: daily until ICU discharge, max until postoperative day 90
measure: total cumulative dose of inopressors per kg bodyweight /hour
timeFrame: until ICU discharge, max until postoperative day 90
measure: time on inopressors
timeFrame: from ICU admission until stop of inopressors, max until postoperative day 90
measure: variation in renal function markers
timeFrame: until postoperative day 6
measure: variation in acid-base homeostasis
timeFrame: until postoperative day 6
measure: variation in immune function
timeFrame: until postoperative day 6
measure: time on the ventilator
timeFrame: from ICU admission until time of extubation, maximum 90 days
measure: occurence of infection
timeFrame: occurence of infection during the index hospitalisation or subsequent admissions due to infection upto 90 postoperative days
measure: length of stay
timeFrame: time to ICU/hospital-discharge however long this may take, maximum 90 days
measure: readmissions to the ICU
timeFrame: readmissions to the ICU within postoperative 90 days
measure: mortality
timeFrame: until postoperative day 90
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland
Study officials:
affiliation: Department of Intensive Care, Inselspital, Bern University Hospital, Bern, Switzerland
name: Joerg C Schefold, MD
role: STUDY_DIRECTOR
References:
citation: Pfortmueller CA, Messmer AS, Hess B, Reineke D, Jakob L, Wenger S, Waskowski J, Zuercher P, Stoehr F, Erdoes G, Luedi MM, Jakob SM, Englberger L, Schefold JC. Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial. Trials. 2019 Jun 14;20(1):357. doi: 10.1186/s13063-019-3420-6.