HERACLES: Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT03280745
Collaborator
(none)
165
1
2
19.1
8.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hypertonic saline
  • Drug: 0.9% saline
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose:
Prevention
Official Title:
Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery
Actual Study Start Date :
Feb 27, 2018
Actual Primary Completion Date :
May 27, 2019
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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.
Other Names:
  • 7.9% NaCl
  • Active Comparator: 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.

    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.
    Other Names:
  • normal saline
  • Outcome Measures

    Primary Outcome Measures

    1. total cumulative amount of fluids infused [daily until ICU discharge, max until postoperative day 90]

    Secondary Outcome Measures

    1. postoperative weight gain [until postoperative day 6]

    2. total postoperative cumulative urinary output [daily until ICU discharge, max until postoperative day 90]

    3. total cumulative dose of inopressors per kg bodyweight /hour [until ICU discharge, max until postoperative day 90]

      cumulation of norepinephrine and epinephrine

    4. time on inopressors [from ICU admission until stop of inopressors, max until postoperative day 90]

      norepinephrine and/or epinephrine

    5. variation in renal function markers [until postoperative day 6]

      renal damage maker (TIMP2-IGFB, creatinine)

    6. variation in acid-base homeostasis [until postoperative day 6]

      pH, base excess, lactate, bicarbonate, electrolytes

    7. variation in immune function [until postoperative day 6]

      mHLA-DR

    8. time on the ventilator [from ICU admission until time of extubation, maximum 90 days]

    9. occurence of infection [occurence of infection during the index hospitalisation or subsequent admissions due to infection upto 90 postoperative days]

    10. length of stay [time to ICU/hospital-discharge however long this may take, maximum 90 days]

      time to ICU/hospital-discharge

    11. readmissions to the ICU [readmissions to the ICU within postoperative 90 days]

    12. mortality [until postoperative day 90]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland Bern Switzerland 3010

    Sponsors and Collaborators

    • University Hospital Inselspital, Berne

    Investigators

    • Study Director: Joerg C Schefold, MD, Department of Intensive Care, Inselspital, Bern University Hospital, Bern, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Inselspital, Berne
    ClinicalTrials.gov Identifier:
    NCT03280745
    Other Study ID Numbers:
    • 201706011.1
    First Posted:
    Sep 12, 2017
    Last Update Posted:
    Mar 24, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 24, 2020