Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery

Cardiovascular Diseases Clinical Trial

— HERACLES  

Official title:

Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280745
• Other study ID #: 201706011.1
• Status: Completed
• Phase: Phase 4
• Start date: February 27, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: September 30, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total cumulative amount of fluids infused		daily until ICU discharge, max until postoperative day 90
Secondary	postoperative weight gain		until postoperative day 6
Secondary	total postoperative cumulative urinary output		daily until ICU discharge, max until postoperative day 90
Secondary	total cumulative dose of inopressors per kg bodyweight /hour	cumulation of norepinephrine and epinephrine	until ICU discharge, max until postoperative day 90
Secondary	time on inopressors	norepinephrine and/or epinephrine	from ICU admission until stop of inopressors, max until postoperative day 90
Secondary	variation in renal function markers	renal damage maker (TIMP2-IGFB, creatinine)	until postoperative day 6
Secondary	variation in acid-base homeostasis	pH, base excess, lactate, bicarbonate, electrolytes	until postoperative day 6
Secondary	variation in immune function	mHLA-DR	until postoperative day 6
Secondary	time on the ventilator		from ICU admission until time of extubation, maximum 90 days
Secondary	occurence of infection		occurence of infection during the index hospitalisation or subsequent admissions due to infection upto 90 postoperative days
Secondary	length of stay	time to ICU/hospital-discharge	time to ICU/hospital-discharge however long this may take, maximum 90 days
Secondary	readmissions to the ICU		readmissions to the ICU within postoperative 90 days
Secondary	mortality		until postoperative day 90