Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery

NCT ID: NCT03280745

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2019-09-30

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.

Conditions

Cardiovascular Diseases; Valvular Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

7.3% NaCl (intervention)

At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl NaCl by infusion pump over 60 minutes.

Group Type: ACTIVE_COMPARATOR

Hypertonic saline

Intervention Type: DRUG

At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl by infusion pump over 60 minutes.

0.9% NaCl (comparator)

At admission to the ICU patients will receive 5ml/kg body weight of 0.9% NaCl by infusion pump over 60 minutes.

Group Type: ACTIVE_COMPARATOR

0.9% saline

Intervention Type: DRUG

At admission to the ICU patients will receive 5ml/kg body weight of 0.9% NaCl by infusion pump over 60 minutes.

Interventions

Hypertonic saline

At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl by infusion pump over 60 minutes.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

7.9% NaCl; normal saline

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joerg C Schefold, MD

Role: STUDY_DIRECTOR

Department of Intensive Care, Inselspital, Bern University Hospital, Bern, Switzerland

Locations

Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 31200756 (View on PubMed)

Other Identifiers

201706011.1

Identifier Type: -

Identifier Source: org_study_id