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Completed

NCT Number: NCT03280745

Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 7.9% NaCl

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.

Other names: normal saline

Primary outcomes

  1. total cumulative amount of fluids infused

    Time frame: daily until ICU discharge, max until postoperative day 90

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: HERACLES

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2017
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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