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Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery (HERACLES)

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ClinicalTrials.gov Identifier: NCT03280745
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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
Cardiovascular Diseases Valvular Heart Disease Drug: Hypertonic saline Drug: 0.9% saline Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 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.
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 : February 27, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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 Name: 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 Name: normal saline




Primary Outcome Measures :
  1. total cumulative amount of fluids infused [ Time Frame: daily until ICU discharge, max until postoperative day 90 ]

Secondary Outcome Measures :
  1. postoperative weight gain [ Time Frame: until postoperative day 6 ]
  2. total postoperative cumulative urinary output [ Time Frame: daily until ICU discharge, max until postoperative day 90 ]
  3. total cumulative dose of inopressors per kg bodyweight /hour [ Time Frame: until ICU discharge, max until postoperative day 90 ]
    cumulation of norepinephrine and epinephrine

  4. time on inopressors [ Time Frame: from ICU admission until stop of inopressors, max until postoperative day 90 ]
    norepinephrine and/or epinephrine

  5. variation in renal function markers [ Time Frame: until postoperative day 6 ]
    renal damage maker (TIMP2-IGFB, creatinine)

  6. variation in acid-base homeostasis [ Time Frame: until postoperative day 6 ]
    pH, base excess, lactate, bicarbonate, electrolytes

  7. variation in immune function [ Time Frame: until postoperative day 6 ]
    mHLA-DR

  8. time on the ventilator [ Time Frame: from ICU admission until time of extubation, maximum 90 days ]
  9. occurence of infection [ Time Frame: occurence of infection during the index hospitalisation or subsequent admissions due to infection upto 90 postoperative days ]
  10. length of stay [ Time Frame: time to ICU/hospital-discharge however long this may take, maximum 90 days ]
    time to ICU/hospital-discharge

  11. readmissions to the ICU [ Time Frame: readmissions to the ICU within postoperative 90 days ]
  12. mortality [ Time Frame: until postoperative day 90 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280745


Contacts
Contact: Carmen A Pfortmueller, MD +41316322111 ext 7726 carmen.pfortmueller@insel.ch
Contact: Joerg C Schefold, MD +41316322111 ext 7703 joerg.schefold@insel.ch

Locations
Switzerland
Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland Recruiting
Bern, Switzerland, 3010
Contact: Carmen A Pfortmueller, MD    0041316322111    carmen.pfortmueller@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Director: Joerg C Schefold, MD Department of Intensive Care, Inselspital, Bern University Hospital, Bern, Switzerland

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03280745     History of Changes
Other Study ID Numbers: 201706011.1
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases