Status:
COMPLETED
Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Cardiovascular Diseases
Valvular Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 compositi...
Eligibility Criteria
Inclusion
- Adult patients undergoing cardiac surgery for ischemic or valvular heart disease
Exclusion
- 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
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT03280745
Start Date
February 27 2018
End Date
September 30 2019
Last Update
March 24 2020
Active Locations (1)
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1
Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland
Bern, Switzerland, 3010