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Completed

NCT Number: NCT01675453

The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.

The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac surgery patients. Systemic inflammatory response initiated by CPB through releasing of several mediators lead to altered endothelial integrity and in consequence the leakage of proteins and fluids from the intravascular to the interstitial compartment is occurred. Increased capillary permeability and decreased colloid osmotic pressure were shown to play a key role for fluid shift and increasing of extravascular water. Further tissue edema can result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to adverse outcomes.

Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid shift from the intracellular and the interstitial spaces of tissue into the intravascular compartment.

The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Edema Heart Diseases Myocardial Ischemia Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novosibirsk Research Institute of Pathology of Circulation

Novosibirsk, Novosibirsk Territory, 630055, Russia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass

Exclusion criteria

  • age >70 years
  • body mass index <18 and >35 kg/m2
  • left ventricular ejection fraction <40%
  • myocardial infarction <6 months before surgery
  • stroke or transient ischemic attack <12 months before surgery
  • diabetes mellitus
  • glomerular filtration rate <90 mL/min
  • emergency surgery
  • hematocrit <30%.

Treatment and study plan

7.2% NaCl plus 6% hydroxyethyl starch 200/0.5

Drug

Other names: HyperHAES

0.9% NaCl

Drug

Other names: Saline

Primary outcomes

  1. Extravascular Lung Water Index

    Time frame: baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1

    Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to "Predicted Body Weight".

Secondary outcomes

  1. Pulmonary Oxygenation

    Time frame: 24 hours

    Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure.

  2. Oxygen Delivery

    Time frame: 24 hours

    Oxygen delivery index (DO2I) will be used to assess this outcome measure.

  3. Cardiac Index

    Time frame: 24 hours

  4. Fluid Balance

    Time frame: 24 hours

    Net fluid balance at the end of surgery equals the sum of all infusions minus the urine output. Net fluid balance at postoperative day 1 equals the sum of all infusions minus the urine output and blood loss.

  5. Inflammation Response

    Time frame: 24 hours

    Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure.

  6. Endothelial Integrity

    Time frame: 24 hours

    Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure.

  7. Plasma Na

    Time frame: 24 hours

  8. Plasma Osmolarity

    Time frame: 24 hours

  9. Rate of Acute Kidney Injury

    Time frame: 48 hours

    serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure.

  10. Rate of Hyperchloremic Metabolic Acidosis

    Time frame: 24 hours

    blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure.

  11. Stroke Volume Index

    Time frame: 24 hours

  12. Rate of Neurological Complications

    Time frame: 24 hours

    Delirium, clinically diagnosed stroke, and encephalopathy.

  13. Blood Loss

    Time frame: 24 hours

    Bleeding from chest tubes

  14. Duration of Mechanical Ventilation

    Time frame: 24 hours

  15. Chloride Loading

    Time frame: 24 h

    The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

The Efficacy and Safety of 7.2% NaCl Plus 6% Hydroxyethyl 200/0.5 in Patients Scheduled for First-time Coronary Artery Bypass Grafting With Cardiopulmonary Bypass.

Acronym: ESHHS

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 30, 2012
Registry last updated
May 27, 2016

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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