Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery

NCT03280745 | Completed Phase 4

• 1 other identifier: 201706011.1
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• total cumulative amount of fluids infused

  daily until ICU discharge, max until postoperative day 90

Secondary Outcomes (12)

• postoperative weight gain

  until postoperative day 6

• total postoperative cumulative urinary output

  daily until ICU discharge, max until postoperative day 90

• total cumulative dose of inopressors per kg bodyweight /hour

  until ICU discharge, max until postoperative day 90

• time on inopressors

  from ICU admission until stop of inopressors, max until postoperative day 90

• variation in renal function markers

  until postoperative day 6

Study Arms (2)

7.3% NaCl (intervention)

ACTIVE COMPARATOR

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

Drug: Hypertonic saline

0.9% NaCl (comparator)

ACTIVE COMPARATOR

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

Drug: 0.9% saline

Interventions

Hypertonic saline DRUG

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

Also known as: 7.9% NaCl

7.3% NaCl (intervention)

0.9% saline DRUG

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

Also known as: normal saline

0.9% NaCl (comparator)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing cardiac surgery for ischemic or valvular heart disease

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

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

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 31200756 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Valve Diseases

Interventions

Saline Solution, Hypertonic; Saline Solution

Condition Hierarchy (Ancestors)

Heart Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions

Study Officials

• Joerg C Schefold, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: September 12, 2017
• Study Start: February 27, 2018
• Primary Completion: May 27, 2019
• Study Completion: September 30, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)