Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery

Phase 4

Completed

• Conditions: Cardiovascular Diseases; Valvular Heart Disease
• Interventions: Drug: 0.9% saline; Drug: Hypertonic saline

• Registration Number: NCT03280745
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-12
• Study Start: 2018-02-27
• Primary Completion: 2019-05-27
• Study Completion: 2019-09-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% NaCl (comparator)	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.
7.3% NaCl (intervention)	Hypertonic saline	At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl NaCl by infusion pump over 60 minutes.

Primary Outcome Measures

Name	Time	Method
total cumulative amount of fluids infused	daily until ICU discharge, max until postoperative day 90

Secondary Outcome Measures

Name	Time	Method
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
mortality	until postoperative day 90
postoperative weight gain	until postoperative day 6
total postoperative cumulative urinary output	daily until ICU discharge, max until postoperative day 90
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

Trial Locations

Locations (1)

Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland; 🇨🇭 Bern, Switzerland